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1. Doxycycline 100 Mg Capsules
2. Doxycycline 100 Mg Capsules

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

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

•    Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet, see section 4.

•    You must talk to your doctor if you do not feel better or if you feel worse after 10 days.

What is in this leaflet:

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

2.    What you need to know before you take Doxycycline Capsules

3.    How to take Doxycycline Capsules

4.    Possible side effects

5.    How to store Doxycycline Capsules

6.    Contents of the pack and other information

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

You may be given Doxycycline 100 mg Capsules by your doctor to treat infections such as:

•    Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis.

• Urinary tract infections e.g. cystitis, urethritis.

•    Acne which is a skin infection.

•    Eye infections.

• Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia.

•    Infections caused by parasites (associated with louse or tick bites).

•    Malaria, when chloroquine is not effective.

Doxycycline 100 mg Capsules is also used to prevent certain infections developing these are scrub typhus, travellers' diarrhoea, malaria and leptospirosis.

Your doctor may want you to take Doxycycline 100 mg Capsules to treat another infection not listed above. You may also be prescribed an additional medicine to take with Doxycycline 100 mg Capsules to treat your infection. If in doubt talk to your doctor.

2.    What you need to know before you take Doxycycline Capsules

If the answer is YES to any of the questions below DO NOT TAKE Doxycycline I00 mg Capsules.

•    Have you been told you are allergic to Doxycycline 100 mg Capsules or any other tetracycline antibiotic?

Are you allergic to any of the other ingredients in Doxycycline 100 mg Capsules listed above?

•    Are you pregnant or trying to become pregnant?

•    Are you breastfeeding?

•    Is this medicine prescribed for a child under the age of 12 years?

• If you are suffering from achlorhydria.

Tetracyclines should not be used during tooth development (during pregnancy, infancy and children below 12 years old) as such use may lead to permanent discolouration or underdevelopment of the teeth (yellow-grey-brown).

Avoid exposure to strong sunlight while taking this medicine. Your skin may be more sensitive to sunburn than normal. If you get a skin rash, itching, redness or severe sunburn when out in strong sunlight or under ultraviolet light (e.g. on a sun bed) stop taking the medicine and check with yourdoctor.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If the answer is YES to any of the following questions tell your doctor before you start Doxycycline 100 mg capsules.

•    Are you likely to be exposed to strong sunlight or ultraviolet light (e.g. onasun bed)?

•    Do you have liver problems?

•    Do you have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid)?

•    Do you have porphyria (a rare disease of blood pigments)?

•    Do you have (or have you ever had) systemic lupus erythematosus? This condition may be worsened by taking Doxycycline 100 mg Capsules.

If you are suspected as having syphilis, your doctor will continue to monitor you after your treatment has stopped.

Can Doxycycline I00 mg Capsules be taken with other medicines?

Some medicines may interfere with Doxycycline 100 mg Capsules. You should tell your doctor if you are taking any of the medicines listed below. Also check with your doctor ifyou are taking any other medicines:

•    Antacids (indigestion remedies), iron preparations, oral zinc or bismuth. Ifyou take these at the same time of day as Doxycycline it may stop this medicine from working properly.

•    Warfarin or coumarins (used to prevent blood clots). A reduced dose of these medicines may be required when taking doxycycline.

•    Oral contraceptives (birth control pills). Use of birth control pills with tetracyclines may impair the effect of the birth control pill and increase the chance of unwanted pregnancy.

•    Penicillin antibiotics (used to treat infections). Doxycycline may reduce the effect of these antibiotics.

•    Alcohol. Alcohol may reduce the effect of Doxycycline.

•    Carbamazepine, phenytoin (medicines used to control epilepsy) and barbiturates (used to control epilepsy or as a sedative).

•    Ciclosporin (used to affect the body's immune response).

•    Methoxyflurane (an anaesthetic). Ifyou are going to have a general anaesthetic for an operation or dental surgery you must tell your anaesthetist or dentist that you are taking Doxycycline 100 mg Capsules.

•    Quinapril

Can you drive whilst taking this medicine?

There is no evidence to suggest that this medicine will affect your ability to drive.

3. Howto take Doxycycline Capsules

Doctors may prescribe different doses to these depending or the infection being treated. Check with your doctor if you are not sure why you have been prescribed the medicine. The label on the pack will tell you what dose YOU should take, how often and for how long to take it. If you are still not sure, ask your doctor or pharmacist. Take Doxycycline 100 mg Capsules with a full glass of water.

•    It is best to take your capsules at the same time(s) each day, when standing or while sitting.

•    It is important not to lie down for at least thirty minutes after taking Doxycycline 100 mg Capsules, so that the capsule can move as swiftly as possible into the stomach and prevent irritation of the throat or oesophagus (canal taking food from the mouth to the stomach).

•    If your stomach is upset, Doxycycline 100 mg Capsules can be taken with milk or a meal.

•    Take the capsules for the full time of treatment, even when you begin to feel better. If you stop taking the capsules too soon, the infection may return.

What to do ifyou take too many capsules?

An occasional extra dose taken by accident is unlikely to be a problem, but if a large overdose has been taken contact your doctor or your nearest hospital Casualty Department immediately.

What to do ifyou miss a dose?

Do not worry. Ifyou forget to take a capsule take it as soon as you can. Take your next capsule at the right time.

How quickly will the treatment start to work?

You should start to feel better within a few days. If you have been given Doxycycline 100 mg Capsules for acne it may be a few weeks before you start to see an improvement.

What ifyou do not feel better?

If your infection gets worse or you do not start to feel better within a few days (except for acne), or a new infection develops, go back and see yourdoctor.

4. Possible side effects

Like many medicines, this medicine may occasionally cause side-effects in some patients, particularly when you first start taking it. These effects may include:

Allergic reactions: All medicines can cause allergic reactions. Serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings, rash or itching (especially affecting the whole body) should be reported to a doctor immediately.

Particular effects of antibiotics in general: Sore or swollen tongue and diarrhoea may occur. A diarrhoeal disease (pseudomembranous colitis) has been reported which may show as watery diarrhoea, fever and cramps. You should contact a doctor immediately if this occurs. Soreness and itching around the back passage and/or genital areas, inflammation around the vagina, or thrush of the vagina or mouth may also occur.

Effects on the blood: Doxycycline may alter the numbers of certain types of blood cells. If you notice that you are bruising easily, have more nose bleeds, or suffer from an increased number of infections and sore throats, you should contact your doctor. Porphyria has been reported and may appear as sensitivity of the skin to sunlight, inflammation of nerves and stomach pains.

Effects on glands and hormones: When taken for a long time, discolouration of thyroid tissue has been reported. However, this medicine does not impair thyroid function.

Effects on the central nervous system (CNS): Headache. Increased pressure in the skull resulting in severe headaches together with blurred and/or double vision and blind spots have been reported. These effects usually disappear upon stopping the medicine, however, permanent loss of vision has been reported. Bulging fontanelles (soft spot on head) of infants has been reported and usually disappears rapidly on stopping the capsules.

Effects on the ears: Tinnitus (ringing or buzzing in the ears) has been reported.

Effects on the heart: Pericarditis (inflammation of the membrane surrounding the heart which may produce fever or chest pain), and an increased heart rate. Flushing and hypotension (low blood pressure) have also been reported.

Effects on the gastrointestinal tract: inflammation and/or ulcers of the gullet have been reported causing stomach pain, loss of appetite, feeling or being sick, heartburn, diarrhoea, difficulty swallowing and a sore or painful tongue or mouth. These symptoms are very unlikely ifyou take the capsules with water while standing or sitting (see "how to take your medicine"). Discolouration and underdevelopment of teeth has been reported after long term use.

Effects on the liver: Changes in liver function tests, hepatitis and jaundice (yellowing of the skin or white of the eyes) has been reported rarely. Liver failure and pancreatitis has been reported rarely. If you suffer from severe stomach pains, you should contact yourdoctor.

Effects on the skin: Severe skin reactions that make you feel unwell, which may be red, and flaking or peeling of skin. You may notice that your skin is very sensitive to light. If you get a skin rash, itching, redness or severe sunburn when out in sunlight or after using a sun bed stop taking the medicine and seek immediate medical advice from your doctor. If you suffer from systemic lupus erythematosus (SLE) you may notice that your condition gets worse.

Effects on the muscles and bones: Aching muscles or joints have been reported.

Effects on the kidneys: an increase in the amount of urea in the blood has been reported. This is detected by a blood test.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    Howto store Doxycycline Capsules

Keep out of the sight and reach of children.

Store below 25°C in a dry place.

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

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.

6.    Contents of the pack and other information

What Doxycycline capsules contain

•    Each capsule contain 100mg of the active ingredient Doxycycline (as Doxycycline hyclate).

•    The capsule shell contains indigocarmine (E132), yellow and black iron oxide (E172), gelatin, titanium dioxide (E171), shellac and potassium hydroxide.

What Doxycycline capsules look like and contents of the pack

Doxycycline 100mg Capsules have opaque green caps and bodies and are printed in white with «100mg».

Doxycycline 100mg Capsules come in pack sizes of 8,10 and 50 capsules.

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Limited 3&4 Quidhampton Business Units Polhampton Lane, Overton, Hampshire RG25 3ED, UK.

Date of last revision:August 2015.