Doxycycline 50mg Capsules

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Doxycycline is and what it is used for
2. What you need to know before you take Doxycycline
3. How to take Doxycycline
4. Possible side effects
5. How to store Doxycycline
6. Contents of the pack and other information

• if you are allergic to doxycycline, any other tetracycline antibiotic or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or trying to become pregnant
• if you are breast-feeding

You should not use Doxycycline capsules during periods of tooth development (pregnancy, infancy or in children below 8 years old) as such use may lead to permanent discolouration (yellow-grey-brown) or affect the proper growth of the teeth.

There may be circumstances (e.g., severe or life-threatening conditions), where your physician may decide that the benefits outweigh this risk in children below 8 years and Doxycycline capsules should be prescribed.

Talk to your doctor or pharmacist before taking Doxycycline if any of the following apply to you:

• you are likely to be exposed to strong sunlight or uv light (e.g. on a sun bed). You should avoid exposure to strong sunlight while taking this medicine as your skin may be more sensitive to sunburn than normal.
• you have kidney or liver problems.
• you have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid).
• you have porphyria (a rare disease of blood pigments).
• you have (or have ever had) systemic lupus erythematosus (an allergic condition that causes joint pain, skin rashes and fever). This condition may be worsened by taking Doxycycline capsules.
• you are suspected as having syphilis. Your doctor will continue to monitor you after your treatment has stopped.
• you have diarrhoea or usually get diarrhoea when you take antibiotics or have suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Doxycycline capsules, tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
• you are taking oral retinoids as there is a higher risk of suffering from increased pressure in your skull (severe headache with change in vision) when taken with Doxycycline capsules.
• you have oesophagitis (inflammation of the oesophagus or gullet).

When used for a long duration, Doxycycline capsules may cause infections that cannot be treated with this antibiotic. Your doctor can explain the signs and symptoms of such types of infection.

If you need to have tests on your urine be sure to let the doctor know you are taking Doxycycline capsules, as this medicine may affect the results of these tests.

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

If you are taking any of the medicines listed below tell your doctor before taking Doxycycline capsules.

• if you are taking penicillin for infection
• if you have the anaesthetic methoxyflurane.

Some medicines can reduce the effectiveness of Doxycycline capsules, these include:

• Antacids (indigestion remedies), iron preparations, oral zinc or bismuth. These should not be taken at the same time of day as Doxycycline capsules.
• Carbamazepine, phenytoin (medicines used to control epilepsy) and barbiturates (used to control epilepsy or as a sedative).

Doxycycline capsules can affect the action of some other medicines, these include:

• any drugs which prevent blood clotting (e.g. warfarin)
• reduced effectiveness of oral contraceptives (birth control pills), any antacids (indigestion remedies) containing calcium, aluminium or magnesium, or any iron preparations
• preparations containing zinc
• bismuth salts (used in the treatment of stomach ulcers and piles)
• carbamazepine or phenytoin (treatments for epilepsy), or any barbiturates (sedatives)
• ciclosporin, a drug used to suppress the body’s natural defences against infection
• Tell your doctor or dentist you are taking Doxycycline if you are due to have surgery (including dental procedures) requiring anaesthetic, as the dose of Doxycycline may need to be reduced or stopped before have an anaesthetic.

Please see section 3 How to take Doxycycline.

Alcohol may reduce the effect of Doxycycline capsules and should be avoided.

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, as this medicine can cause problems with the colour and development of teeth and the bone development of the unborn child or young infant.

Ask your doctor or pharmacist for advice before taking this medicine.

Doxycycline capsules must not be taken if you are pregnant or breast-feeding.

This medicine should not affect your ability to drive or use machines.

If you take too much Doxycycline capsules, contact your doctor or nearest hospital immediately. Please take this leaflet and the labelled medicine package with you, whether there are any Doxycycline capsules left or not.

If you forget to take a capsule, take it as soon as you can. Take your next capsule at the right time. Do not take a double dose to make up for a forgotten dose.

You should continue to take these capsules for as long as your doctor tells you to. Take the full course. Even if you start to feel better the original infection may still be present and may recur if treatment is stopped.

Stop taking Doxycycline and see a doctor or go to a hospital straight away if you notice the following side effects after taking this medicine. Although they are very rare, the symptoms can be severe.

• Sudden wheeziness, difficulty in breathing, chest pain, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
• Upset stomach, loss of appetite, severe, persistent or bloody diarrhoea (this may occur up to two or three months after the last dose and may be associated with stomach pain or fever). This may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
• Very severe headache which may be associated with visual disturbances such as blurred vision, double vision or loss of vision. Permanent visual loss has been reported.
• Serious illness with widespread severe blistering of the skin, mouth, eyes and genitals. This may be due to Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) such as skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine), as they may be signs of a hypersensitivity reaction or toxic epidermal necrolysis, which are serious illnesses. Also, the separation of the distal nail from the nail bed.
• worsening of the symptoms of systemic lupus erythematosus (SLE) an autoimmune condition which causes joint pain, skin rash and fever.
• Increased pressure in the brain.

If any of the side effects listed below occur, contact your doctor as soon as possible.

• The Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting doxycycline treatment for infections with spirochete such as Lyme disease.
• Skin that is more sensitive to sunlight than normal. You may get a skin rash, itching, redness or severe sunburn. If this happens stop taking the medicine and tell your doctor.
• Inflammation and/or ulcers of the gullet.
• Blood disorders. These are due to changes in numbers of different cell types in the blood. Symptoms may include tiredness, easy bruising or infections.
• Low blood pressure.
• Increased heart rate.
• Aches in the joints or muscles.
• Stomach pain and diarrhoea.

The side effects listed below may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you:

Common (may affect up to 1 in 10 people)

• feeling or being sick
• worsening of a disease called systemic lupus erythematous (SLE). This is an allergic condition which causes joint pain, skin rash, fever and headache
• pericarditis (inflammation affecting the heart)

Uncommon (may affect up to 1 in 100 people)

• heartburn
• vaginal infection

Rare (may affect up to 1 in 1,000 people)

• anxiety
• difficulty in swallowing, sore or painful tongue or mouth
• skin reddening (flushing)
• a ringing or buzzing noise in the ear
• soreness and itching of the rectal and/or genital area
• inflammation of the bowel
• bulging fontanelles (soft spot on head) of infants
• increased pressure in the skull (severe headache with change in vision)
• inflammation and damage to the liver
• abnormal liver function tests
• discolouration of the thyroid tissue when given for long periods. The medicine does not impair thyroid function
• loosening of the nail from the nail bed after exposure to the sun
• increased levels of urea in the blood
• yellow skin and eyes (jaundice), inflammation of the pancreas
• upset stomach, loss of appetite, diarrhoea (this may occur up to two or three months after the last dose), stomach pain
• darker patches on your skin

Not known: frequency cannot be estimated from the available data

• discolouration and/or lack of growth of teeth

If you get any side effects, talk to your doctor or pharmacist. 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.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is Doxycycline Hyclate.

Each Doxycycline 50 mg capsule contains 50 mg of doxycycline equivalent to approximately 57.71 mg of doxycycline hyclate.

Each Doxycycline 100 mg capsule contains 100 mg of doxycycline equivalent to approximately 115.41 mg of doxycycline hyclate.

The other ingredients are: Hypromellose, Sodium lauryl sulphate, Microcrystalline cellulose, Magnesium stearate.

The capsule shell contains: gelatin and titanium dioxide (E171).

Doxycycline 100 mg capsules also contain Brilliant Blue (E133) and Iron Oxide Yellow (E172).

Doxycycline 50 mg capsules are unmarked, hard, white coloured capsules.

Doxycycline 100 mg capsules are unmarked, hard, green coloured capsules.

Doxycycline 50 mg capsules are available in blister packs of 14 and 28 capsules.

Doxycycline 100 mg capsules are available in blister packs of 8, 14 and 50 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer