Clomidep 25 mg Film-Coated Tablets

CLOMIDEP is used to treat depression, including recurrent depressive disorders or major depression. Other psychological conditions that can be treated with CLOMIDEP are:

• Obsessive compulsive disorders
• Muscular weakness (cataplexy) associated with recurrent attacks of extreme sleepiness (narcolepsy) in adults.
• In children aged above 5 years, CLOMIDEP is used to treat obsessive-compulsive disorders.

Do not take CLOMIDEP:

• if you are hypersensitive (allergic) to clomipramine, any other tricyclic antidepressants, or to any of the other ingredients in CLOMIDEP
• if you are taking MAO-inhibitors (certain medicines used for depression), a washout period of 14 days is required before you start or stop taking CLOMIDEP due to the potential for severe interactions, severe hypertensive reactions (very high blood pressure), hyperpyretic crisis (extremely high fever), convulsions and fatalities.

Warnings and precautions

Take special care with CLOMIDEP:

• if you have heart disease such as congestive heart failure; blockage of the heart where the electrical signal that controls your heartbeat is partially or completely blocked; irregular or abnormal heartbeats
• if you have narrow angle glaucoma (increased pressure within the eyeball)
• if you have difficulty or problems passing urine
• if you have severe liver or kidney disease
• if you are prone to getting convulsions or seizures as a result of brain damage, epilepsy or alcoholism
• if you have a tumor of the adrenal medulla (an area close to the kidneys) in whom the medicine may provoke hypotensive crisis (huge drop in blood pressure).
• if you are thinking about suicide
• if you have schizophrenia or other mental disorders
• if you have any blood disorder
• if you have an overactive thyroid gland
• if you have persisting constipation
• if you have low blood pressure
• if you are diabetic

Your doctor will take these conditions into account before and during your treatment with CLOMIDEP. Ensure that CLOMIDEP tablets is kept out of reach of children, as relatively small overdoses may be fatal to them. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking CLOMIDEP.

Do not share medicines prescribed for you with any other person. Always take CLOMIDEP exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults: The usual dose is 1 tablet (25 mg) 2 to 3 times daily and gradually increased by 1 more tablet (25 mg), as tolerated, every 3 to 4 days up to a total daily dose of 6 tablets (150 mg).

Children (5 years of age and older) and adolescents: The usual dose is 1 tablet (25 mg) daily during the first two weeks and gradually, increased over several weeks, up to a total daily dose of 3 mg/kg or 8 tablets (200 mg), whichever is smaller.

Your doctor will tell you how long your treatment with CLOMIDEP will last. Do not stop treatment early because the tablets take a while before they start to have an effect. If you have the impression that the effect of CLOMIDEP is too strong or too weak, tell your doctor or pharmacist.

If you take more CLOMIDEP than you should

You may feel drowsy, confused, experience dryness of the mouth, enlarged pupils, vomiting, cyanosis, restlessness, agitation, severe perspiration, hyperactive reflexes, muscle rigidity and convulsions. An extremely high fever, bowel and bladder paralysis and respiratory and cardiac depression may also occur. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take CLOMIDEP

Do not take a double dose to make up for forgotten individual doses.

If you stop taking CLOMIDEP

It is important for you to keep taking CLOMIDEP tablets until your doctor decides to stop them. If you stop taking CLOMIDEP, the depressive conditions may return. This could be dangerous.

CLOMIDEP can have side effects. Not all side effects reported for CLOMIDEP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLOMIDEP, please consult your health care provider for advice.

If any of the following happens, stop taking CLOMIDEP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• You have an allergic reaction. The signs may include: shortness of breath, wheezing, difficulty breathing, rash, itching, hives on the skin, swelling of your lips, face or throat.
• You get a headache, dizziness, feel confused or have a seizure. These are all very serious side effects. If you have them, you may have had a serious reaction to CLOMIDEP. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• acute or persistent infections which present as a severe sore throat, fever, fatigue.
• hyperpyrexia (extremely high fever)
• palpitations
• dysrhythmias
• cold sweats
• chest pain
• hypertension
• hypotension (low blood pressure) symptoms of hypotension may include light headedness, dizziness, fainting, blurred vision; fast shallow breathing, fatigue
• severe or persistent diarrhoea
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems
• oedema.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• anorexia
• increased appetite
• weight gain
• speech disorders
• tremor
• feeling of pins and needles in the fingers or toes
• sudden, brief involuntary twitching or jerking of a muscle or group of muscles
• impaired memory
• Impaired concentration
• manic disorders
• aggravated depression
• restlessness
• seeing or hearing things
• feeling disorientated
• anxiety, nervousness
• nightmares
• yawning
• inability to sleep (insomnia)
• visual changes such as dilation of the pupils with blurred vision or increased eye pressure
• ringing in ears(tinnitus)
• hot flushes
• sweating
• high levels of a family of liver enzymes called transaminases
• pink or red skin rash with blotchy blisters, scaly patches, or raised spots on areas directly exposed to the sun that may burn or itch (photosensitivity)
• muscle weakness
• tension in the muscles
• changed libido, ejaculatory failure, or impotence
• enlargement of breast
• persistent or intermittent milky nipple discharge (galactorrhoea).

• Store all medicine out of reach of children.

• Store at or below 25 °C in a cool, dry place, protected from light.

• Store in the original package.

• Keep the blister strip in the outer carton.

• Protect from moisture.

• Do not store in a bathroom.

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

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).