Doxycycline 50mg Capsules
TEVA UK Ref: 231-30-87600-C LEA DOXYCYCLINE A/S CAP TUK Version: 3 10 March 2016
PAGE 1: FRONT FACE (INSIDE OF REEL)
Doxycycline
50mg & 100 mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
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. Content of the pack and other information
OWHAT DOXYCYCLINE IS AND WHAT IT IS USED FOR
Doxycycline is a tetracycline antibiotic. Doxycycline is used:
• for the treatment of infections e.g. soft tissue and skin infections (including acne), eye infections, infections of the lungs, sinuses and urinary tract, pneumonia, bronchitis, sexually transmitted diseases, gangrene, tetanus, malaria, bacterial infections caught from contaminated water or certain animals (e.g. cattle, poultry and rodents) and louse and tick-borne infections and fevers • for the prevention of infections e.g. malaria, travellers' diarrhoea, leptospirosis (a disease caused by bacterium) and scrub typhus (a disease spread by mites).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXYCYCLINE
DO NOT take Doxycycline:
• If you are allergic (hypersensitive) to doxycycline, any other tetracycline antibiotic, or any of the other ingredients of this medicine
• If you are a child under 12 years of age, as this medicine can cause permanent discolouration of the teeth (yellow-grey-brown) during tooth development and may also cause problems with the development of tooth enamel
• If you are pregnant, planning to become pregnant or breast-feeding, as this medicine can cause problems with the colour and development of teeth and the bone development of the unborn child or young infant.
Take special care with Doxycycline Warnings and precautions
Talk to your doctor before taking Doxycycline if you:
• have liver problems
• have oesophagitis (inflammation of the oesophagus or gullet)
• suffer from porphyria (a deficiency of specific enzymes within the body causing an increase of substances called porphyrins)
• suffer from systemic lupus erythematous (SLE, an autoimmune condition which causes joint pain, skin rash and fever)
• suffer from myasthenia gravis (a disorder in which the muscles are weak and tire easily)
• are likely to be exposed to strong sunlight or ultra violet light
• are aware you are suffering from syphilis.
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.
Other medicines and Doxycycline DO NOT take Doxycycline if you are:
• taking penicillins for infection
• to have the anaesthetic methoxyflurane.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following:
• any drugs which prevent blood clotting (e.g. warfarin)
• 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 you have an anaesthetic.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Doxycycline capsules contains lactose
Patients who are intolerant to lactose should note that Doxycycline Capsules contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Doxycycline with food, drink and alcohol
• DO NOT drink alcohol if you are taking Doxycycline, as alcohol may affect the amount of time Doxycycline stays in your blood.
Pregnancy, breast-feeding and fertility
• DO NOT take Doxycycline if you are pregnant, think you may be pregnant or are 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 for advice before taking any medicine
Driving and using machines
Doxycycline is not known to affect your ability to drive or operate machinery.
^ HOW TO TAKE DOXYCYCLINE
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The capsules should be taken with plenty of water. If you find that your stomach becomes irritated after taking Doxycycline, you can take the capsules with food or with milk. You should be sitting or standing to take the dose, DO NOT take whilst lying down. Make sure you take the capsules well before going to bed.
The dosage is dependant on the infection being treated. The recommended dose is:
Adults (including the elderly) and children over 12 years of age:
200 mg on the first day taken either as a single dose or divided into two doses. This is then followed by 100 mg or 200 mg daily for the rest of the treatment depending on the severity of the infection.
Specific infections:
• Acne
50 mg once daily taken with food or water for 6-12 weeks.
• Sexually transmitted diseases
100 mg twice daily for 7 or 10 days depending on the infection.
• Syphilis
200 mg twice daily for 2 weeks.
• Louse and tick-borne fever
A single dose of 100 mg or 200 mg depending on the severity of the infection.
• Chloroquine-resistant malaria
200 mg a day for at least 7 days. You will also be given another medicine as well as Doxycycline for this infection.
Prevention of:
• Malaria
100 mg daily one or two days before travel followed by 100 mg daily during the stay and for four weeks after leaving the area.
• Leptospirosis
200 mg once each week during the stay in the area and a final dose of 200 mg on completion of the visit. If your course of treatment is exceeds 21 days, please consult your doctor.
Top of page cut-off to middle of registration mark: 44 mm.
REG0022183
Version 3.5
Approved
Page 1 of 3
PAGE 2: REAR FACE (OUTSIDE OF REEL)
• Scrub typhus
200 mg as a single dose.
• Travellers' diarrhoea in adults
200 mg on the first day of travel, taken as either a single dose or divided into two doses and taken 12 hours apart, followed by 100 mg daily during the visit. If your course of treatment is exceeds 21 days, please consult your doctor. Children under 12 years of age Doxycycline must not be used in children under 12 years of age.
If you take more Doxycycline than you should
If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.
If you forget to take Doxycycline
If you forget to take a capsule, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Doxycycline
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, or severe skin rash or hives.
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation
Stop taking your capsules and tell your doctor immediately if the following occurs:
• blistering of the skin, mouth, eyes and genitalia; 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
• problems with sight such as blurred vision, double vision, a blind spot in your field of vision, and loss of vision
• increased pressure in the brain.
Rare side effects (may affect up to 1 in 1,000 people):
• headache
• feeling sick, being sick, diarrhoea, stomach pains and indigestion
• loss of appetite
Very rare side effects (may affect up to 1 in 10,000 people):
• abdominal pain
• discoloration of teeth and alteration of tooth enamel may also occur, though this is usually only obvious after long term use.
• increased sensitivity to sunlight or ultra-violet light
• muscle and joint pain
Not known (Not known from the available data):
• increased heart rate
• low blood pressure
• flushing
• ringing in the ears
• dermatitis (inflammation of the skin)
• vaginal (or anal) thrush or soreness
• inflammation of the bowel
• inflammation of the tongue
• inflammation or ulcers in the oesophagus (gullet) and difficulty in swallowing
• porphyria, a deficiency of specific enzymes within the body, causing an increase of substances called porphyrins. These deficiencies can cause a wide variety of symptoms, including discolouration of the urine, serious skin disorders, anaemia, abdominal pains and severe mental disorders
• other disorders of the blood may occur which may be characterised by fever or chills, sore throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises
• liver problems such as jaundice (yellowing of the skin and whites of the eyes), hepatitis, changes in the results of liver function tests
• pancreatitis (inflammation of the pancreas, with symptoms such as nausea, vomiting, stomach and back pain)
• inflammation of the heart
• signs of super infection (i.e. black furry tongue)
Reporting of side effects:
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.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
^ HOW TO STORE DOXYCYCLINE
Keep this medicine out of the sight and reach of children.
Keep the container tightly closed in order to protect from light. Do not transfer them to another container.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C in the original pacakage.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
©CONTENTS OF THE PACK AND OTHER INFORMATION
What Doxycycline capsules contain:
• The active ingredient is 50 mg or 100 mg doxycycline as doxycycline hyclate.
• The other ingredients are lactose, maize starch and magnesium stearate (E572).
The capsule shell contains gelatin and the following colours: patent blue V (E131), titanium dioxide (E171), erythrosine (E127) and quinoline yellow (E104).
The printing ink contains shellac, black iron oxide (E172), and propylene glycol (E1520). What Doxycycline capsules look like and contents of the pack:
• Doxycycline 50 mg capsules are white/green hard, size 3 gelatin capsules filled with a yellow powder with a twin triangle logo on the body, and "DOX 50" printed on the cap in black in.
• Doxycycline 100 mg capsules are green/green hard, size 3 gelatin capsules filled with a yellow powder with a twin triangle logo on the body, and "DOX 100" printed on the cap in black ink • The capsules are available in pack sizes of 8, 10, 14, 20, 28, 30, 50, 100 capsules.
• The 100 mg capsules are also available in packs of 250, 500, 1000, or 100,000 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: Teva UK Limited,
Eastbourne, BN22 9AG
This leaflet was last revised: February 2016
PL 00289/1424-1425
tHrW71
87600-C 160 x323
REG0022183
Version 3.5
Approved
Page 2 of 3
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
1.3.2 mockup- pil-uk-pl-00289-1424&5-doxycycline 50mg & 100mg capsules
Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Divya Jain |
Regulatory Affairs Approval |
13-Apr-2016 08:38:21 AM |
REG0022183 Version 3.5 Approved Page 3 of 3