CLOPRESS

Clomipramine 10mg & 25mg Tablets

What is in this leaflet

This leaflet answers some common questions about CLOPRESS. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor has weighed the risks of using CLOPRESS against the
benefits expected it will have for you. If you have any concerns about using
this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What CLOPRESS is used for and how it works

Your CLOPRESS tablets contain clomipramine hydrochloride. It belongs to a
group of medicines known as tricyclic antidepressants (TCAs).

CLOPRESS is used to treat depression. Depression is thought to be caused by a
chemical imbalance in parts of the brain. This affects your whole body and can
cause emotional and physical symptoms such as feeling low in spirit, loss of
interest in activities, being unable to enjoy life, poor appetite or overeating,
disturbed sleep, often waking up early, loss of sex drive, lack of energy and
feeling guilty over nothing. CLOPRESS works by correcting this chemical
imbalance and may help relieve the symptoms of depression.

CLOPRESS is also used to treat obsessive-compulsive syndromes, phobias, panic
attacks, muscle weakness in people with a sleep disorder called narcolepsy, and
chronic painful conditions.

Your doctor may, however, prescribe CLOPRESS for another reason. Ask your
doctor if you have any questions about why CLOPRESS has been prescribed for you.

CLOPRESS is not recommended for use in children 12 years of age and under.
CLOPRESS is not recommended for use in adolescents (13-18 years of age) for the
treatment of depression, unless under the supervision of a specialist.

CLOPRESS is available on prescription from your doctor.

Before you take CLOPRESS

When you must not take it

Do not take CLOPRESS if:

  • You are allergic to clomipramine, other tricyclic antidepressants or
    any other ingredients listed at the end of this leaflet
  • You are taking another medicine for depression called a monoamine
    oxidase inhibitor (MAOI) or have been taking a MAOI within the last 14 days.
    Ask your doctor or pharmacist if you are unsure as to whether or not you are
    taking a MAOI
  • You have recently had a heart attack.

Symptoms of an allergic reaction may include shortness of breath, wheezing or
difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Before you take it

Tell your doctor if:

  • You have had an allergic reaction to any medicine that you have taken
    previously to treat your current condition
  • You have heart or liver problems
  • You have difficulty passing urine
  • You have epilepsy, fits or convulsions (or a condition such as alcoholism,
    brain damage or a recent head injury which might make fits more likely to
    occur)
  • You are pregnant, plan to become pregnant or are breastfeeding
  • You suffer from an overactive thyroid gland (hyperthyroidism) or are
    receiving thyroid medication
  • You suffer from raised pressure in the eye (glaucoma)
  • You suffer from chronic constipation
  • You suffer from phaeochromocytoma or neuroblastoma (rare tumours of the
    adrenal gland)
  • You suffer from low or high blood pressure
  • You have suicidal thoughts or have attempted suicide in the past
  • You suffer from mania (mood of excitement, over-activity and uninhibited
    behaviour) or bipolar disorder
  • You have allergies to any other medicines, foods, preservatives or dyes.

Taking other medicines

If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.

Medicines that may interfere with CLOPRESS include:

  • Monoamine Oxidase Inhibitors (e.g. moclobemide, phenelzine,
    tranylcypromine)
  • Other antidepressants (e.g. SSRIs and tricyclic antidepressants)
  • Adrenergic Neurone Blockers (e.g. guanethidine, betanidine,
    reserpine, clonidine)
  • Sympathomimetics, such as nasal decongestants (used for colds or
    hay fever)
  • CNS Depressants (e.g. barbiturates, benzodiazepines)
  • Anticholinergic Agents (e.g. phenothiazine, antiparkinsonian
    agents, antihistamines)
  • Quinidine
  • Liver-Enzyme Inducers (e.g. barbiturates, carbamazepine, phenytoin,
    nicotine)
  • Neuroleptics
  • Anticoagulants (e.g. warfarin)
  • Cimetidine (used to treat ulcers and other stomach complaints)
  • Methylphenidate
  • Oestrogens (e.g. oral contraceptive pill or hormone replacement
    therapy).

These medicines may be affected by CLOPRESS or may affect how well CLOPRESS
works. You may need different amounts of your medicines or you may need to take
different medicines.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking CLOPRESS.

How to take CLOPRESS properly

How much to take

Your doctor will tell you how much CLOPRESS you need to take each day. It is
important that you take CLOPRESS as directed by your doctor. Do not take more
than the recommended dose.

It may take up to 4 weeks before any response to CLOPRESS is noticeable.

For Depression, Obsessive-Compulsive Syndromes and Phobias

Treatment is usually started with 25mg of clomipramine 2 or 3 times daily.
If necessary, your doctor may increase the dose up to a maximum of 250mg a day.
The usual maintenance dose is 50 to 100mg per day.

For Panic Attacks, Agoraphobia

Treatment is usually started with a dose of 10mg daily. If necessary, your
doctor may increase the dose up to a maximum of 150mg a day. The usual
maintenance dose is 25 to 100mg per day.

For Muscle Weakness Accompanying Narcolepsy

The dose is usually 25 to 75mg daily.

For Chronic Painful Conditions

The daily dose varies (10 to 150mg) depending on your condition.

If you are elderly, you may be started on a dose of 10mg daily. Your doctor
may increase your dose over a period of about ten days, to 30-50mg daily.

Your doctor may tell you to take different doses to these. If so, follow
their instructions.

The tablet(s) should be swallowed whole with a glass of water.

How long to take it

For depression, the treatment is usually continued for at least six months to
prevent potential recurrence. You may not feel better immediately as most
antidepressants take time to work. Do not stop taking CLOPRESS even if you begin
to feel better, unless your doctor tells you to do so. Make sure you do not run
out of tablets.

If you forget a dose

If you forget a dose, just take the next dose when it is due. Do not take
more than one dose at a time to make up for missed doses.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

While you are taking CLOPRESS

Tell all doctors, dentists and pharmacists who are treating you that you are
taking CLOPRESS.

Tell your doctor or pharmacist that you are taking CLOPRESS before you start
any new medicine.

Tell your doctor if you develop a skin rash or hives, or you become pregnant
while taking CLOPRESS.

If you are going to have surgery, tell the surgeon or anaesthetist that you
are taking CLOPRESS.

If you are going to have any blood tests, tell your doctor that you are
taking CLOPRESS.

Keep all appointments you and your doctor have scheduled so that your
progress can be followed.

Tell your doctor if you notice any of the following, especially if they
are severe, abrupt in onset, or were not part of your presenting symptoms:
anxiety, agitation, panic attacks, insomnia (difficulty sleeping), irritability,
hostility (aggressiveness), impulsivity, akathisia (restlessness or difficulty
sitting still), hypomania, mania (mood of excitement, over-activity and
uninhibited behaviour), worsening of depression.

Tell your doctor immediately if you have any distressing thoughts (thought
of suicide or self-harm) or experiences during this initial period or at any
other time.

Do not take CLOPRESS to treat any other complaints unless your doctor tells
you to.

Do not stop taking CLOPRESS or lower the dose without first checking with
your doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar
to yours.

CLOPRESS may cause drowsiness in some people. Be careful when driving,
operating machinery or performing jobs that need you to be alert, until you are
certain that CLOPRESS does not affect your performance.

Your doctor may suggest avoiding alcohol while you are being treated for
depression.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well
while you are taking CLOPRESS.

All medicines can have some unwanted effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of
the side effects.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

  • Stomach or bowel problems (e.g. nausea, diarrhoea, constipation)
  • Drowsiness
  • Dry mouth or taste change
  • Increased sweating
  • Increased appetite
  • Shakiness or tremor
  • Changes in your sex drive
  • Dizziness
  • Tiredness
  • Headache
  • Weakness
  • Impaired concentration or thought processes
  • Trouble sleeping
  • Vision problems
  • Irregular heart beats, also called palpitations.

These are the more common side effects of CLOPRESS.

Tell your doctor immediately if you:

  • Develop a rash or hives while taking CLOPRESS.

This side effect is rare but serious. You may need urgent medical
attention.

See your doctor if you experience any of the following when you stop CLORESS
treatment:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhoea
  • Insomnia (difficulty sleeping)
  • Headache
  • Nervousness
  • Anxiety.

The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please tell
your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any CLOPRESS by mistake. Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical attention.
Take the pack of
CLOPRESS with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Do not take this medicine after the expiry date shown on the pack/blister
strip or if the packaging shows signs of tampering.

Keep your CLOPRESS tablets in the blister pack until it is time to take them.

Store below 25°C and out of reach of children. Avoid exposure to heat, light
and moisture.

Do not store CLOPRESS, or any other medicine, in the bathroom or near a sink.

Disposal

If your doctor tells you to stop taking CLOPRESS or if the tablets have
passed the expiry date, ask your pharmacist what to do with the remaining
medicine.

Product Description

What CLOPRESS tablets look like

CLOPRESS 10mg tablets are white, film coated biconvex tablets.

CLOPRESS 25mg tablets are yellow, film coated biconvex tablets.

CLOPRESS 10mg tablets are available in blister packs of 100 tablets.

CLOPRESS 25mg tablets are available in blister packs of 500 tablets.

Ingredients

CLOPRESS 10mg tablets contain 10mg of the active ingredient, clomipramine
hydrochloride. CLOPRESS 10mg tablets also contain lactose, maize starch,
povidone, sodium starch glycollate, magnesium stearate, contents of an organic
film coat (isopropyl alcohol, chloroform, diethyl phthalate, hypromellose,
opaspray white) and carnauba wax.

CLOPRESS 25mg tablets contain 25mg of the active ingredient, clomipramine
hydrochloride. CLOPRESS 25mg tablets also contain lactose, maize starch,
povidone, sodium starch glycollate, quinoline yellow lake, magnesium stearate,
contents of an organic film coat (ethanol, chloroform, diethyl phthalate,
hypromellose, opaspray yellow) and carnauba wax.


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