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Doxycycline Capsules Bp 50mg

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Document: leaflet MAH GENERIC_PL 04416-0264 change

PACKAGE LEAFLET: INFORMATION FORTHE USER SZ00000LT000

Doxycycline Capsules BP 50 mg


Doxycycline hyclate

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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Doxycycline capsules are and what they are used for

2.    Before you take Doxycycline capsules

3.    How to take Doxycycline capsules

4.    Possible side effects

5.    How to store Doxycycline capsules

6.    Further information



IWhat Doxycycline Capsules are and what they are used for

The name of your medicine is Doxycycline Capsules BP 50 mg.

The active substance doxycycline belongs to a group of medicines known as antibiotics or anti-bacterial agents.


While taking Doxycycline you should avoid exposure to strong sunlight or ultraviolet light, you could develop skin reactions or redness and will have to stop taking this medicinal product.

You may need to use this product for at least 10 days if you have a certain type of infection (Group A beta haemolytic streptococci).


Doxycycline may be used to treat a wide range of

infections caused by bacteria, these include:

•    respiratory tract infections such as pneumonia, bronchitis or whooping cough

•    urinary tract infections

•    sexually transmitted diseases such as chlamydia, gonorrhoea or syphilis

•    skin infections such as acne

•    infections of the eye such as conjunctivitis

•    rickettsial infections such as Q fever or tick fever

•    other infections including brucellosis, psittacosis, plague, cholera

•    Doxycycline may also be used to treat leptospirosis, gasgangrene and tetanus.


Before you take Doxycycline Capsules


Do not take Doxycycline capsules and tell your doctor if

you:

•    are allergic or have previously been allergic to doxycycline, tetracycline antibiotics or any of the other ingredients in this medicine (see section 6 Further information).

•    are or might be pregnant or breast-feeding.

•    are giving it to a child under 12 years of age.

Take special care with Doxycyline capsules and tell your

doctor if you:

•    suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech.

•    have kidney or liver disease

•    you have venereal disease (VD), you will need to have some tests; your doctor will inform you of this.


Your doctor may need to monitor you to ensure that this medicinal product is effective.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important that you tell your doctor if you are taking:

   Anticoagulants (used to prevent blood clotting).

   Penicillin (used to treat infections).

   Antacids (particularly those containing aluminium, calcium or zinc).

   Bismuth chelates (used to treat toxic poisoning).

   Sucralfate (used to treat stomach ulcers).

   Iron-containing compounds (includes drugs for anaemia).

   Methoxyflurane (powerful pain killer).

   Barbiturates (for sedation, anaesthetic or to treat fits).

   Carbamazepine (for fits and mental disorders).

   Primidone (for fits).

   Phenytoin (for epileptic fits).

   Oral contraceptives (birth control pills or “The Pill”).

   Ciclosporins (used to prevent rejection during organ transplant).

Pregnancy and breast-feeding

Do not take doxycycline if you are or might be pregnant as it can harm your developing baby.

Do not take doxycycline if you are breast-feeding as it may harm the tooth development of your baby.

Driving and using machines

Doxycycline can cause nausea, if this occurs, you should avoid driving, operating machinery or any other activity requiringfull alertness.    Continued on the next page >>


Important information about some of the ingredients of Doxycycline Capsules

Doxycycline Capsules contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.


How to take Doxycycline Capsules


Always take Doxycyline capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the tablets one hour before or two hours after meals followed by a glass of water. Swallow the tablets when standing or sitting down, do not take them immediately before going to bed.

The usual dose is:

Adults and children over 12 years of age:

First day

One dose of 4 capsules (200mg) to be taken on the first day as a single dose

Or


•    Pain and swelling of the mouth and throat.

•    Difficulty swallowing.

•    Skin rashes or redness.

•    Skin peeling.

If you have systemic lupus erythematosus (SLE), taking doxycycline may make your condition worse. Your doctor will inform you of this.

Tell your doctor if the following side effects occur:

•    Stomach upset.

•    Nausea (feeling sick).

•    Vomiting (being sick).

•    Loss of appetite (anorexia).

•    Diarrhoea.

•    Pain and discomfort in passing stools.

•    Sensitivity to sunlight or strong light.

•    Severe headaches.

•    Bruising and bleeding easily.

•    Feeling of tiredness, low energy and prone to infection.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Two doses of 2 capsules (100mg) to be taken separately with an interval of 12 hours on the first day. (2 capsules to be taken in the morning and 2 in the evening).

Following days

This should be followed by a maintenance does of 2 capsules (100mg) a day.

For severe infections, 4 capsules (200mg) may be given throughout the treatment period.

Children under 12 years of age:

Doxycycline Capsules are not recommended for use in children under 12 years of age as it can cause permanent discoloration of tooth enamel and affect bone development.

If you take more Doxycycline Capsules than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take Doxycycline Capsules

If you have forgotten to take your medicine, take it as soon as you remember. If your next dose is due within 6 hours, take a single dose now and skip the next. Do not take a double dose to make up for the forgotten dose. If you are concerned, consult your doctor or pharmacist.

If you stop taking Doxycycline Capsules

Do not stop treatment early as your infection may return if you do not finish the course of capsules.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


How to store Doxycycline Capsules


Keep out of reach and sight of children.

Do not take Doxycycline Capsules after the expiry date shown on the label. The expiry date refers to the last day of that month.


Keep this medicine in a dry place.

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 to protect the environment.


Further information


Possible side effects


Like all medicines, Doxycycline capsules can cause side effects, although not everybody gets them.


What Doxycycline Capsules contain

Each capsule contains doxycycline hyclate BP equivalent to 50mg of the active substance doxycycline.

The other ingredients include: maize starch, magnesium stearate, talc and lactose. The capsule shell consists of a green cap made up of E172, E132, E171 and gelatin, and a white body made up of E171 and gelatin.

What Doxycycline Capsules look like and contents of the pack

Doxycycline capsules are hard, gelatine capsules with a white, opaque body and green cap.

These capsules are supplied in packs of 28, 30, 56, 60, 84, 100, 150, 168 and 200.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is: Sandoz Ltd, WoolmerWay, Bordon, Hants, GU35 9QE.

The manufacturer is: Clonmel Healthcare Ltd, Clonmel, Ireland.

This leaflet was last approved in: 05/2008 (to be amended on approval).


Stop taking the capsules immediately and contact your doctor straight away or seek emergency help immediately if the following occur:

• Swelling of the tongue.


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