Document: leaflet MAH GENERIC_PL 23138-0003 change

• leaflet MAH BRAND_PL 23138-0003
• leaflet MAH GENERIC_PL 23138-0003

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxepin

25mg and 50mg Capsules

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

Keep this leaflet. You may need to read it again. If you have any further questions, please 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Doxepin Capsules are and what they are used for

2.    Before you take Doxepin Capsules

3.    How to take Doxepin Capsules

4.    Possible side effects Capsules

5.    How to store Doxepin Capsules

6.    Further information

1. WHAT DOXEPIN CAPSULES ARE AND WHAT THEY ARE USED FOR

The name of this medicine is Doxepin 25mg and 50mg Capsules. The active ingredient is doxepin hydrochloride. Doxepin is an antidepressant. It is one of a group called tricyclic antidepressants.

Your doctor has decided that this medicine is suitable for treating your depression.

Depression is a clinical illness. If you have been feeling sad, tearful or unable to enjoy life as you used to, Doxepin Capsules may help you to feel better. It may also help if you have difficulty sleeping because of your depression. If you are not sure why you are on these capsules, ask your doctor.

2. BEFORE YOU TAKE DOXEPIN CAPSULES

Do not take Doxepin Capsules if:

•    You have ever had an allergic reaction to tricyclic antidepressants, doxepin, or any of the inactive ingredients of Doxepin Capsules

(see ‘Further information’section)

•    You have serious liver problems

•    You have glaucoma (increased eye pressure)

•    You suffer from difficulty in passing urine

•    You are breast-feeding

•    You are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs for short)

•    You suffer from a type of mood disorder called mania, where you experience an abnormally elevated mood state.

•    The patient is under 12 years of age

If you suffer from any of the above, speak to your doctor or pharmacist before taking Doxepin Capsules.

Take special care with Doxepin Capsules if:

•    You are pregnant or trying to become pregnant

•    You have any heart problems

•    You have had a heart attack recently

•    You have kidney problems

•    You suffer from epilepsy (fits)

•    You have suicidal thoughts or have attempted suicide in the past

If you answer YES to any of the above questions talk to your doctor before taking this medicine.

If you are taking other medicines

It is very important that you inform your doctor if you are taking or have taken any other medicines, as some medicines may affect the way Doxepin Capsules works.

If you are going to have a surgical operation or dental surgery tell the doctor or dentist in charge that you are taking this medicine.

Some medicines can interfere with the action of Doxepin Capsules and Doxepin Capsules can sometimes affect the action of other medicines. Check with your doctor if you are taking any of the medicines listed below:

•    Monoamine oxidase inhibitors. These must not be used with Doxepin Capsules (see ‘Beforeyou take Doxepin Capsules’ section above)

•    Other antidepressants, barbiturates (used to treat insomnia) or other sleeping medicines or medicines for anxiety. Doxepin Capsules will add to their effects and may cause you to feel sleepy or drowsy.

•    Medicines to lower blood pressure.

•    Sympathomimetics, such as nasal decongestants (used for colds or hay fever) and bronchodilators (used to treat asthma).

•    Cimetidine (used to treat ulcers and other stomach complaints).

•    Thyroid hormones (used to treat thyroid disorders).

•    Chlorpromazine (used to treat mental illness).

•    Sublingual nitrates (used to treat angina and heart failure).

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or trying to become pregnant without consulting your doctor.

Do not take this medicine if you are breast-feeding without consulting your doctor.

Driving and using machines

You may feel sleepy when you take these capsules, do not drive or work with machinery until this effect has worn off.

Alcohol and Doxepin Capsules

Be careful when drinking alcohol. Alcoholic drinks (wine, beer, spirits) may affect you much more than usual.

3. HOW TO TAKE DOXEPIN CAPSULES

The label on the pack will tell you what dose YOU should take and how often each day to take it. If you are still not sure, ask your doctor or pharmacist.

Your medicine should only be taken by mouth. Swallow your capsules whole with a drink of water. Take the capsules while standing or when sitting upright.

Do not crush or chew the capsules.

Keep taking the capsules every day

The usual starting dose is 75mg daily. This dose

may be increased if necessary.

The maximum recommended dose is 100mg three times daily.

If you are elderly these doses may be reduced.

If you are elderly and require an increased dose of the medicine your doctor may wish to see you regularly.

If you suffer from liver problems you may also be started on a low dose.

The capsules may be prescribed once, twice or three times daily.

Up to 100mg can be given as a single dose.

If you take more Doxepin Capsules than you should

Too many capsules at once can be dangerous. Signs and symptoms of mild overdosage include drowsiness, stupor, blurred vision and excessive dryness of the mouth. Severe overdosage may cause loss of consciousness, reduced breathing rate, convulsions, low blood pressure, unusually fast heart beat or palpitations. If you take too many capsules immediately contact your doctor or nearest hospital Accident and Emergency Department. Do not attempt to drive or work with machinery.

If you forget to take Doxepin Capsules

Do not worry. Take your usual dose at the next correct time.

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

If you stop taking Doxepin Capsules

You should always check with your doctor before you stop treatment. Your doctor may want you to reduce gradually the amount you are taking before stopping the medicine completely. This may help to prevent a recurrence of the original trouble and reduce the chance of withdrawal effects such as insomnia, irritability and excessive sweating.

How quickly will the treatment start to work?

•    You may take Doxepin Capsules for 2-3 weeks before you start to feel better.

•    You must keep taking Doxepin Capsules to help you get better.

•    See your doctor before your capsules run out.

•    Even if you begin to feel better, keep taking your capsules. You may need to keep taking them to stay well.

What if you do not feel better?

Tell your doctor if:

•    You have taken all your medicine and you still feel unwell:

or

•    You feel worse.

4. POSSIBLE SIDE EFFECTS Thoughts of suicide and worsening of your depression or anxiety disorder.

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:

-    If you have previously had thoughts about killing or harming yourself.

-    If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Bone fractures

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Doxepin is well tolerated. Most undesirable effects are usually mild and tend to wear off after continued treatment. However, if the side effects are troublesome, your doctor may decide to reduce your dose.

The most common side effects are:

•    Drowsiness

•    Dry mouth

•    Constipation

These are usually mild. If they last for more than several days, check with your doctor.

Less common or rare side effects listed below. If they don’t wear off after a few days or trouble you, check with your doctor.

•    Dizziness, (if you experience dizziness you should be particularly careful to stand up slowly).

•    Sweating.

•    Blurred vision.

•    Headache.

•    Insomnia.

•    Difficulty in passing urine.

•    Tiredness.

•    Weakness.

•    Weight gain.

•    Upset stomach.

•    Loss of appetite.

•    Vomiting or diarrhoea.

•    Mouth ulcers.

•    Unpleasant taste.

•    Fast heart beat (palpitations).

•    Changes in sex drive.

•    Swelling of testicles

•    Chills.

•    Flushing.

•    Hair loss from the scalp.

•    Shakiness or trembling.

•    Numbness in the hands or feet.

•    Feeling of pins and needles.

•    Agitation or confusion.

•    Ringing or buzzing in the ears.

-    Worsening of asthma.

-    Convulsions (fits) are unlikely unless you already suffer from these.

-    Nightmares, hallucinations (seeing or hearing things that are not there), jaundice (yellow eyes or skin).

-    Changes to the heart rhythm may occur very rarely. Blood disorders; these may cause fever or chills and painful ulceration in the mouth or rectum; unusual bruising or bleeding.

-    Abnormal blood tests results i.e.- change in blood sugar levels, lower sodium content of blood and low blood cell count.

Elderly patients: If you are elderly, you may be more likely to be troubled by agitation or confusion

It is important to tell your doctor or pharmacist if you suffer any of these or any other undesirable effects which are not listed above.

5. HOW TO STORE DOXEPIN CAPSULES

Do not take Doxepin Capsules after the date stamped on the pack.The expiry date refers to the last day of the month.

Doxepin Capsules should be kept in a cool, dry place (below 25°C).

Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

What Doxepin Capsules contain

The capsules are free of gluten and sucrose.

Doxepin 25mg Capsule. Each capsule contains 25mg doxepin. Other ingredients: lactose, maize starch, magnesium stearate and sodium lauryl sulphate. The gelatin capsules are coloured with amaranth (E123), erythrosine, (E127), patent blue V (E131), sunset yellow (E110) and titanium dioxide (E17l).

Doxepin 50mg Capsule. Each capsule contains 50mg doxepin. Other ingredients: lactose, maize starch, magnesium stearate and sodium lauryl sulphate. The gelatin capsules are coloured with erythrosine, (E127), patent blue V (E131) and titanium dioxide (E171).

What Doxepin Capsules look like and the contents of the pack

Doxepin 25mg Capsules (blue and red) come in packs of 28.

Doxepin 50mg Capsules (blue) come in packs of 28.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Marlborough Pharmaceuticals Ltd

35A High Street, Marlborough, UK, SN8 1LW

Manufacturer

Allphamed PHARBIL GmbH

Hildebrandstrasse 12, D-37081 Gottingen, Germany

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Rare side effects: The undesirable effects below are rare but they have occurred in patients taking one of the tricyclic antidepressants, however, not all have occurred with Doxepin. You should check with your doctor immediately if any of the following occur:

-    Skin rash, itching, face swelling. Your skin may be more sensitive to sunlight than it is normally.

-    At high doses particularly in the elderly, unwanted effects on muscles which may cause slowed movements or stiffness of arms and legs, slurred speech or odd tongue or eye movements.

-    Staggering walk which may occur on a mixture of centrally acting drugs.

-    Worsening of an existing mental disorder;

-    Breast enlargement in both men and women, breast milk production when not pregnant or breast feeding;