Lybrel

In the US, Lybrel (ethinyl estradiol/levonorgestrel systemic) is a member of the drug class contraceptives and is used to treat Abnormal Uterine Bleeding, Birth Control, Endometriosis, Gonadotropin Inhibition, Ovarian Cysts and Polycystic Ovary Syndrome.

US matches:

• Lybrel

Ingredient matches for Lybrel

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Lybrel in the following countries:

• United States

Levonorgestrel

Levonorgestrel is reported as an ingredient of Lybrel in the following countries:

• United States

International Drug Name Search

Sotalol Sandoz

Sotalol Sandoz may be available in the countries listed below.

Ingredient matches for Sotalol Sandoz

Sotalol

Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of Sotalol Sandoz in the following countries:

• Belgium


• France


• Germany

International Drug Name Search

CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH ORIGINAL FLAVOUR 0.2% W / V OROMUCOSAL SOLUTION

1. Name Of The Medicinal Product

CHLORHEXIDINE GLUCONATE ANTISEPTIC MOUTHWASH ORIGINAL FLAVOUR 0.2% W/V OROMUCOSAL SOLUTION

2. Qualitative And Quantitative Composition

Chlorhexidine Gluconate 0.2% w/v

Excipients:

Ponceau 4R 0.001% w/w

Macrogol glycerol hydroxystearate 0.7 % w/w

For full list of excipients see Section 6.1

3. Pharmaceutical Form

Oromucosal Solution

A clear pink solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery or in physically handicapped patients). It is used to promote gingival healing following periodontal surgery, to manage recurrent oral ulceration. Additionally it is useful in the treatment of denture stomatitis and thrush.

4.2 Posology And Method Of Administration

Children, adults and the elderly.

Chlorhexidine Gluconate Antiseptic Mouthwash should be used as required up to twice daily.

Rinse the mouth thoroughly for about 1 minute with 10 ml. Prior to dental surgery, the patient should be instructed to rinse the mouth with 10 ml for 1 minute. In the treatment of gingivitis a course of about one month is recommended (ie two bottles). For denture stomatitis cleanse and soak the denture in solution for 15 minutes twice daily. In the case of aphthous ulceration and oral candidal infections, treatment should be continued for 48 hours after clinical resolution.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For oral use only. Keep away from the eyes and ears. If solution comes into contact with the eyes, wash out well with water. Keep out of the reach and sight of children.

Ponceau 4R may cause allergic reactions.

Macrogol glycerol hydroxystearate may cause skin reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine Gluconate 0.2% is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Chlorhexidine Gluconate Antiseptic Mouthwash (rinsing the mouth between applications) or at a different time of the day.

4.6 Pregnancy And Lactation

Chlorhexidine has been in widespread use for many years and no harmful effects in human pregnancy have been reported. However as with all drugs, caution should be exercised. Chlorhexidine Gluconate Antiseptic Mouthwash should be used only when the benefit to the mother has been assessed by a clinician.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Irritative skin reactions to chlorhexidine can occur occasionally. Generalised allergic reactions to chlorhexidine have also been reported but are extremely rare.

A superficial discolouration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discolouration of the teeth and silicate or composite restorations may also occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash. However, in certain cases, a professional prophylaxis (scaling and polishing) may be required to remove this stain completely. Stained anterior tooth-coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement. Similarly where normal toothbrushing is not possible, as for example with intermaxillary fixation or with extensive orthodontic appliances, scaling and polishing may also be required once the underlying conditions have been resolved.

Transient disturbances of taste sensation and a burning sensation of the tongue may occur on initial use of the mouthwash. These effects usually diminish with continued use.

In cases where oral desquamation occurs it may be necessary to discontinue treatment. Very occasionally, swelling of the parotid glands during the use of oral chlorhexidine has been reported. In all cases spontaneous resolution has occurred on discontinuing treatment.

System Organ Class	Very Common ( 10%)	Common (	Uncommon (	Rare (	Very Rare (
Gastrointestinal Disorders			Tooth discolouration Tongue discolouration		Oral mucosal exfoliation (desquamation) Parotid gland enlargement
Immune System Disorders					Hypersensitivity
Nervous System Disorder		Dysgeusia (taste altered)
Skin and Subcutaneous Tissue Disorders				Skin irritation

4.9 Overdose

Chlorhexidine is poorly absorbed by the oral route, therefore systematic effects are unlikely even if large volumes are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chlorhexidine gluconate is a bisguanide antiseptic and disinfectant which is bactericidal or bacteriostatic against a wide range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophylic viruses. The antimicrobial activity covers most of the important species occurring in the oral microflora.

5.2 Pharmacokinetic Properties

Because of its cationic nature, chlorhexidine (gluconate) binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chlorhexidine Gluconate Antiseptic Mouthwash contains the following inactive ingredients:

Ethanol

Sorbitol

Macrogol glycerol hydroxystearate

Original Flavour: E2309 10 N1

Ponceau 4R

Purified Water

6.2 Incompatibilities

Chlorhexidine Gluconate Antiseptic Mouthwash is incompatible with anionic agents which are often present in toothpastes. Therefore these should be used before the mouthwash, rinsing the mouth between applications, or at a different time of day.

Hypochlorite bleaches may cause brown stains to develop in fabrics previously in contact with chlorhexidine.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original container in order to protect from light

6.5 Nature And Contents Of Container

Amber PET bottle with a polypropylene screw cap. The cap is conical in shape and has “10 ml” and a level line engraved on the inside. The pack contains 300 ml.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

12^th March 2008

10. Date Of Revision Of The Text

9^th June 2011

Buscon

Buscon may be available in the countries listed below.

Ingredient matches for Buscon

Scopolamine

Scopolamine is reported as an ingredient of Buscon in the following countries:

• Bangladesh

Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Buscon in the following countries:

• Myanmar

International Drug Name Search

Gaviscon Extra Strength 500 Peppermint Tablets.

1. Name Of The Medicinal Product

Gaviscon Extra Strength 500 Peppermint Tablets.

2. Qualitative And Quantitative Composition

Each tablet contains sodium alginate 500mg, sodium bicarbonate 267mg and calcium carbonate 160mg.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Chewable tablet.

An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of peppermint.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and acid indigestion, for example, following meals or during pregnancy.

4.2 Posology And Method Of Administration

For oral administration, after being thoroughly chewed.

Adults and children 12 years and over: One to two tablets after meals and at bedtime.

Children under 12 years: Should be given only on medical advice.

Elderly: No dose modifications necessary for this age group.

4.3 Contraindications

None.

4.4 Special Warnings And Precautions For Use

The sodium content of two-tablet dose is 246 mg (10.6 mmol). This should be taken into account when highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.

Each two-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

Due to its aspartame content this product should not be given to patients with phenylketonuria.

There is a possibility of reduced efficacy in patients with very low levels of gastric acid.

If symptoms do not improve after seven days, the clinical situation should be reviewed.

Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience Gaviscon Extra Strength 500 Peppermint Tablets may be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.

4.9 Overdose

In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification: A02BX 13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

On ingestion Gaviscon Extra Strength 500 Peppermint Tablets react rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.

5.2 Pharmacokinetic Properties

The mode of action of Gaviscon Extra Strength 500 Peppermint Tablets is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings of relevance to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lemon flavour no. 1

Marcrogol 20,000

Mannitol (E421)

Copovidone

Aspartame (E951)

Acesulfame potassium (E950)

Magnesium stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 30°C. Store in the original package.

6.5 Nature And Contents Of Container

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blister trays into cartons.

Blister tray containing six or ight individually sealed tablets. Two, four, six or eight blister trays in a carton.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

No Data Held

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0138

9. Date Of First Authorisation/Renewal Of The Authorisation

7 October 2003

10. Date Of Revision Of The Text

17/10/2005

Vivitrol

Pronunciation: nal-TREX-one
Generic Name: Naltrexone
Brand Name: Vivitrol

Vivitrol may cause liver problems when given in large doses. Do not use Vivitrol if you have hepatitis or liver failure. Contact your doctor right away if you develop symptoms of liver problems. Symptoms may include severe or persistent stomach pain, pale bowel movements, yellowing of the eyes or skin, or dark urine.

Vivitrol is used for:

Treating alcohol addiction in certain patients. It is also used to prevent opioid (narcotic) pain medicine use in opioid-dependent patients following detoxication treatment. Vivitrol is used along with a complete management program. It may also be used for other conditions as determined by your doctor.

Vivitrol is a narcotic antagonist. Exactly how Vivitrol works to decrease alcohol use is not known. It is thought to decrease opioid use by blocking their effects. Vivitrol does not decrease alcohol or opioid withdrawal symptoms.

Do NOT use Vivitrol if:

• you are allergic to any ingredient in Vivitrol or to the solution used to mix Vivitrol


• you are taking a narcotic pain medicine (eg, codeine), a narcotic cough/cold medicine (eg, hydrocodone), or certain medicines used for diarrhea (eg, diphenoxylate), or you have taken any narcotic within the past 7 to 10 days


• you are dependent on narcotics, have had a positive urine test for narcotics, or are having withdrawal symptoms from narcotics


• you have hepatitis or liver failure

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vivitrol:

Some medical conditions may interact with Vivitrol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney or liver problems, blood or bleeding problems (eg, hemophilia, low blood platelets), mental or mood problems, or suicidal thoughts or actions


• if you have recently had an alcoholic drink

Some MEDICINES MAY INTERACT with Vivitrol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain medicines used for diarrhea (eg, diphenoxylate), narcotic cough/cold medicines (eg, hydrocodone), or narcotic pain medicines (eg, codeine) because their effectiveness may be decreased by Vivitrol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivitrol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vivitrol:

Use Vivitrol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Vivitrol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vivitrol refilled.


• Vivitrol is usually given as an injection at your doctor's office, hospital, or clinic.


• Vivitrol should be given every 4 weeks (once a month).


• If you miss a dose of Vivitrol, contact your doctor as soon as possible to reschedule your dose.

Ask your health care provider any questions you may have about how to use Vivitrol.

Important safety information:

• Vivitrol may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Vivitrol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Vivitrol has only been shown to decrease alcohol or opioid use as part of a complete treatment program. Be sure to follow the program given to you by your doctor or health care provider.


• Do not begin to use Vivitrol if you are actively drinking. Tell your doctor if you have recently had an alcoholic drink.


• Carry an ID card at all times that says you use Vivitrol.


• Mild pain, redness, swelling, itching, bruising, tenderness, or hardness of the skin around the injection site may occur with Vivitrol. Tell your doctor if you experience any skin problems that bother you, do not get better, or get worse within 2 weeks after your injection. Contact your doctor right away if you notice symptoms of a severe injection-site reaction (eg, severe pain, severe swelling or hardness of the skin, lumps, blisters, skin color changes, dark scabbing, an open wound at the injection site).


• Tell your doctor or dentist that you take Vivitrol before you receive any medical or dental care, emergency care, or surgery.


• Family and caregivers must closely observe patients who take Vivitrol. Tell the doctor right away if the patient has symptoms like depression or suicidal thoughts or actions.


• Do not use any narcotics (eg, codeine, heroin) while you are using Vivitrol. Using large doses of narcotics while you are using Vivitrol could cause a serious injury, coma, or death.


• After you stop using Vivitrol, you may be more sensitive to narcotics. Even very low doses of narcotics may cause serious and sometimes life-threatening breathing or circulation problems after you stop using Vivitrol.


• Lab tests, including liver function and complete blood cell counts, may be performed while you use Vivitrol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Vivitrol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vivitrol while you are pregnant. Vivitrol is found in breast milk. Do not breast-feed while taking Vivitrol.

If you are addicted to narcotics and you use Vivitrol, you may experience WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Vivitrol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; headache; joint pain or stiffness; loss of appetite; mild nausea; mild pain, redness, swelling, itching, bruising, tenderness, or hardness of the skin around the injection site; muscle cramps; sore throat; stomach pain; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; chest, jaw, or left arm pain; confusion; cough; dark urine; fainting; fast or irregular heartbeat; fever; new or worsening mental or mood problems (eg, depression); numbness of an arm or leg; one-sided weakness; pain, redness, or swelling in the legs; pale stools; seizures; severe or persistent constipation or stomach pain; shortness of breath; slurred speech; sudden, severe headache or vomiting; suicidal thoughts or actions; symptoms of a severe injection-site reaction (eg, severe pain, severe swelling or hardness of the skin, lumps, blisters, skin color changes, dark scabbing, an open wound at the injection site); vision changes; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Vivitrol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe drowsiness, dizziness, nausea, or stomach pain.

Proper storage of Vivitrol:

Vivitrol is usually handled and stored by a health care provider. If you are using Vivitrol at home, store Vivitrol as directed by your pharmacist or health care provider. Keep Vivitrol out of the reach of children and away from pets.

General information:

• If you have any questions about Vivitrol, please talk with your doctor, pharmacist, or other health care provider.


• Vivitrol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vivitrol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Vivitrol resources

• Vivitrol Side Effects (in more detail)
• Vivitrol Use in Pregnancy & Breastfeeding
• Vivitrol Drug Interactions
• Vivitrol Support Group
• 6 Reviews for Vivitrol - Add your own review/rating

• Vivitrol Consumer Overview


• Vivitrol Advanced Consumer (Micromedex) - Includes Dosage Information


• Vivitrol Prescribing Information (FDA)


• Naltrexone Prescribing Information (FDA)


• Naltrexone Monograph (AHFS DI)


• naltrexone Advanced Consumer (Micromedex) - Includes Dosage Information


• Revia Prescribing Information (FDA)

Compare Vivitrol with other medications

• Alcohol Dependence
• Opiate Dependence

Co-tenidone Tablets 50 / 12.5mg, 100 / 25mg

Co-tenidone 50/12.5mg and

100/25mg tablets

(atenolol and chlortalidone)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

1 What Co-tenidone tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Co-tenidone tablets are and what they are used for

Co-tenidone tablets may be used to control high blood pressure.

Before you take

Do not take Co-tenidone tablets and tell your doctor if you have:

• an allergy (hypersensitivity) to atenolol, chlortalidone, sulphonamide derived medicines or any of the other ingredients in Co-tenidone tablets (see section 6)


• second or third degree heart block


• 
  shock caused by heart problems


• 
  cramping pains causing limping (intermittent claudication)


• severe kidney or liver failure.


• 
  breathing problems (reversible obstructive airways disease) e.g. asthma or bronchitis. Do not take this medicine if you have a history of wheezing or asthma. Consult your doctor or pharmacist first


• 
  heart failure which is not under control


• a slow heart rate


• 
  low blood pressure
  


• 
  severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)


• an increased acidity of the blood (metabolic acidosis)


• 
  untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney)


• 
  heart conduction or rhythm problems (sick sinus syndrome)


• are pregnant or breastfeeding

Take special care with Co-tenidone tablets and tell your doctor if you:

• have a tight, painful feeling in the chest in periods of rest (Prinzmetal’s angina)


• have poor liver function/liver disease


• have first degree heart block


• have poor heart function


• have heart disease or failure


• have diabetes mellitus


• have stomach or intestine problems causing a loss of potassium from the body


• have or have had high levels of uric acid in the blood, gout or severe joint pain


• are on a low-potassium diet


• are elderly


• have a history of allergic reactions


• suffer from treated phaeochromocytoma (high blood pressure due to a tumour near the kidney)


• have any thyroid problems


• have problems with blood circulation


• will be undergoing surgery where an anaesthetic will be used

Taking other medicines

Before taking Co-tenidone tablets, tell your doctor if you are taking or have recently taken any of the following medicines, or are taking any non-prescribed medicines.

• adrenaline (epinephrine, used in anaphylactic shock)


• amphetamines


• sympathomimetic agents (in decongestant, asthma or heart medicines)


• ergotamine (to treat migraines)


• anti-arrhythmic drugs (to treat irregular heart beats)


• clonidine (to treat high blood pressure)


• nifedipine and verapamil (to treat heart diseases)


• aluminium hydroxide (in indigestion remedies)


• medicines containing calcium


• chemotherapy drugs (to treat cancer)


• medicines to treat diabetes


• lithium (for psychiatric disorders)


• cardiac glycosides e.g. digoxin and digitoxin (to treat heart conditions)


• aminoglycosides


• indomethacin, ibuprofen (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs))


• anaesthetics


• tubocurarine, baclofen (muscle relaxants)

Pregnancy and breast feeding

Co-tenidone tablets are not recommended during pregnancy or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Co-tenidone tablets may cause you to have low blood pressure (dizziness and lightheadedness) or a slow heart beat. Make sure you are not affected before driving or operating machinery.

Tests

During long-term treatment your doctor may want to carry out tests, especially in those with diabetes, stomach or intestine problems, a low-potassium diet, the elderly or those taking cardiac glycosides.

How to take

Always take Co-tenidone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with water.

Usual doses:

• 
  Adults: 1 tablet a day


• 
  Children: Not recommended

If you are elderly or have impaired kidney function, your doctor may prescribe you a different dose.

If you take more than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Overdose causes an excessively slowed heart beat and low blood pressure with feeling sick, difficulty breathing, weakness, dizziness, increased production of urine and changes in the levels of certain chemicals in the body.

If you forget to take to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking the tablets

Do not stop treatment early, especially if you have ischaemic heart disease. Talk to your doctor before you stop taking the tablets and follow their advice.

Possible side effects

Like all medicines, Co-tenidone can cause side effects, although not everybody gets them.

Stop treatment and contact a doctor at once if you have the following symptoms of an allergic reaction e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects, they get worse or you notice any not listed:

Common (occurs in less than 1 in 10 users):

• slow heart beat


• cold extremities


• stomach and intestinal discomfort or pain, feeling sick


• tiredness


• gout


• increased levels of sugar in the blood

Uncommon (occurs in less than 1 in 100 users):

• sleep disturbances


• increase in liver enzymes (may cause itching and jaundice)

Rare (occurs in less than 1 in 1,000 users):

• your medicine may alter the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to give you a blood test


• nightmares, mood changes, seeing or sensing things that are not there


• confusion, dizziness, headache, visual disturbances


• worsening of heart failure, heart block symptoms causing fainting and irregular heart beat, low blood pressure on standing causing dizziness and fainting


• worsening of intermittent claudication and Raynaud’s phenomenon, ‘pins and needles’


• difficulty breathing


• dry mouth/eyes


• yellowing of the skin or whites of the eyes (jaundice), inflammation of the pancreas or kidneys causing pain and tenderness in the abdomen and back (pancreatitis or interstitial nephrititis)


• hair loss (alopecia), worsening of psoriasis, skin rashes


• changes in sex drive or potency

Other (frequency cannot be estimated from the data):

• constipation


• aching and tired muscles


• fits and coma (caused by low levels of sodium, magnesium and potassium in the blood)

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Protect from light.

Do not use after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Ask your pharmacist how to dispose of medicines no longer required.

Further information

What Co-tenidone tablets contain

• The active substances (the ingredients that make the tablets work) are atenolol and chlortalidone. The 50/12.5mg tablets contain 50mg atenolol and 12.5mg chlortalidone. The 100/25mg tablets contain 100mg atenolol and 25mg chlortalidone.


• The other ingredients are macrogol, magnesium stearate, maize starch, polyvidone, sodium starch glycollate, titanium dioxide (E171), Iron oxide red (E172), calcium hydrogen phosphate (E341), microcrystalline cellulose (E460) and methylhydroxypropylcellulose (E464).

What Co-tenidone tablets look like and the contents of the pack

Co-tenidone tablets are brownish pink, circular, biconvex, film-coated tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in July 2010

Actavis

Barnstaple

EX32 8NS

UK

50411545