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DOXYCYCLINE CAPSULES 100MG

Active substance(s): DOXYCYCLINE HYCLATE / DOXYCYCLINE HYCLATE / DOXYCYCLINE HYCLATE

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doxycycline
#100 mg
capsules

Lot

EXP

doxycycline
#100 mg
capsules

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22

100
mg

Doxycycline 100 mg
Capsules, Hard

• 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.

Package leaflet: Information for the patient

Doxycycline 100 mg
Capsules, Hard

8 capsules
Each capsule contains: Doxycycline hyclate
equivalent to 100 mg of doxycycline.
Dosage: For oral use as directed by a doctor.
Read the package leaflet before use.
Keep out of sight and reach of children.
Store in the original package in order to protect
from light and moisture. Store below 25°C

What is 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. Contents of the pack and other information
1. What Doxycycline is and what it is used for
Doxycycline belongs to the tetracycline group of
antibiotics. Doxycycline can be used to treat a variety

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.

PL 04569/0035 POM
991580 LL0448AG
Mylan, Potters Bar, Herts, EN6 1TL, UK.

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1

of infections, including bacterial infections that
affect the eyes, nose, throat and respiratory system
(chest infections), eye infections, sexually transmitted
diseases and infections of the urinary tract; malaria,
fevers associated with lice, fleas and tick bites or
diseases spread by animals (e.g. leptospirosis); and in
the prevention of traveller’s diarrhoea, scrub typhus,
leptospirosis and malaria.
2. What you need to know before you
take Doxycycline

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Do not take Doxycycline
• if you are allergic to doxycycline, a similar medicine or
any of the other ingredients of this medicine (listed in
section 6)
• if you are pregnant, trying to become pregnant or
breast-feeding
• if you are a child under 12 years old, as tetracyclines






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
discolouration and/or lack of growth of teeth
aches in the joints or muscles

Not known (frequency cannot be estimated from the
available data):
• vaginitis, discharge and itching in the vagina due
to infection
• inflammation of the mouth and lips
Your blood tests may show:
• reduction in the number of white blood cells
• a rise in blood urea
• abnormal liver function

What Doxycycline looks like and the contents of
the pack.
Your medicine comes as green capsules, containing
yellow powder marked with “DE 100” with “G”.
Doxycycline is available in glass or plastic bottles or
blister packs of 5, 7, 8, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60,
84, 90, 100 and 250 capsules.
Not all pack sizes may be marketed.

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What Doxycycline contains
• The active substance is doxycycline hyclate, equivalent
to 100 mg of doxycycline.
• The other ingredients are magnesium stearate, talc,
maize starch. The capsule shell is made of gelatin and
contains the colourings patent blue (E131), titanium
dioxide (E171) and iron oxides (E172). The printing ink
contains shellac, titanium dioxide (E171), propylene
glycol, and either ammonium hydroxide and
simeticone, or sodium hydroxide and povidone.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
This leaflet was last revised in 01/2017
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Other medicines and Doxycycline
Please tell your doctor if you are taking any other
medicines including medicines obtained without a
prescription, herbal medicines or any of the following:
• anticoagulants to thin the blood e.g. warfarin
• antacids, used for indigestion containing aluminium,
calcium, magnesium
• sucralfate used to treat stomach or gut ulcers
• zinc sulphate
• bismuth
• preparations containing iron
• barbiturates used to control epilepsy or as a sedative
e.g. phenobarbital
• antiepileptics e.g. carbamazepine, phenytoin
• penicillin antibiotic used to treat infections
• ciclosporin used to affect the body’s immune response
following organ transplants

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• oral contraceptives (birth control pills)
If you are going to have an operation and need an
anaesthetic, tell the anaesthetist or dentist you are
taking Doxycycline.
Doxycycline with alcohol
Do not drink alcohol during treatment.
Pregnancy and breast-feeding
Do not take Doxycycline if you are pregnant, think you
may be pregnant, or plan to become pregnant, as it can
affect the development of your unborn baby.
Do not breast-feed if you are taking Doxycycline as
doxycycline can pass into breast milk.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

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can affect growing bones and teeth and can also cause
staining and a reduction in the amount of enamel in
the teeth
Warnings and precautions
Talk to your doctor or pharmacist before taking
Doxycycline
• if you have kidney or liver problems
• if you suffer from a rare disorder called porphyria
• if you suffer from myasthenia gravis (a disease causing
muscle weakness)
• if you have SLE (systemic lupus erythematosus)
Avoid strong sunlight or ultra violet light as Doxycycline
can make the skin more sensitive. If your skin becomes
red and patchy, tell your doctor as he may need to
stop treatment.
If you are having tests, such as liver function tests or a
urine test, tell your doctor you are taking Doxycycline.

Adults and older people
The recommended dose is two capsules (200 mg) on
the first day (either as a single dose or one capsule
followed by a further 100 mg capsule 12 hours later),
followed by one 100 mg capsule daily thereafter. To treat
more serious infections your doctor may prescribe two
capsules (200 mg) to be taken daily.
The following doses may be given to treat
specific infections:
Sexually transmitted diseases: the recommended dose
is 100 mg twice daily. Depending on the type of infection
being treated, your treatment may continue for between
7 to 10 days.

• Inflammation and/or ulcers of the gullet
• Inflammation of the pancreas which causes severe pain
in the abdomen and back
• Severe diarrhoea with blood in the stools
• Pericarditis (inflammation of the membrane around
the heart)
• Haemolytic anaemia (low number of red blood cells).
Signs include tiredness, headaches, being short of
breath when exercising, dizziness with yellowing of the
skin and/or eyes
• Inflammation and damage to the liver. Signs include
nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes,
light coloured bowel motions, dark coloured urine
• Blood disorders, these are due to changes in the
numbers of different cell types in the blood. Symptoms
may include tiredness, easy bruising or injections.

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If you are suspected as having syphilis. Your doctor
will continue to monitor you after your treatment
has stopped.
If 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
tell your doctor immediately since it may be necessary
to interrupt the treatment. This may be a sign of bowel
inflammation (pseudomembraneous colitis) which can
occur following treatment with antibiotics.
When used for a long duration, Doxycycline may cause
infections that cannot be treated with this antibiotic.
Your doctor can explain the signs and symptoms of such
types of infection.

Reporting of side effects
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.
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Doxycycline
Keep out of the sight and reach of children.
Do not take Doxycycline after the expiry date which is
stated on the label or carton after “EXP”. The expiry date
refers to the last day of that month.
Store in the original package in order to protect from
light and moisture. Store below 25°C.

Stop taking Doxycycline and tell your doctor if your
skin becomes sensitive to sunlight or UV light. You may
get a skin rash, itching, redness or serve sunburn.

Driving and using machines
Do not drive or use machines if you suffer from
visual disturbances such as blurred vision while
taking Doxycycline.
3. How to take Doxycycline
Always take Doxycycline exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
You must complete the course of treatment as directed
by your doctor, even if you feel better.
• Swallow the capsules with plenty of fluid.
• Take the capsules with milk or food to reduce the
likelihood of stomach upset.
• Take whilst sitting or standing upright: this medicine
should not be taken immediately before bedtime or
if lying down.

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Uncommon (may affect up to 1 in 100 people):
• heartburn
• dyspepsia
• gastritis

Other side effects include:

Rare (may affect up to 1 in 1,000 people):
• upset stomach, loss of appetite, diarrhoea (this, may
occur up to two or three months after the last dose),
stomach pain
• 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
• thrush or fungal infections
• bulging fontanelles (soft spot on head) of infants
• abnormal liver function tests
• discolouration of the thyroid tissue when given

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 and fever
• rash including maculopapular and
erythematous rashes
• headache
• swollen ankles
• Increased heart rate
• Low blood pressure

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Patients being treated for certain diseases may need
monthly blood tests to check the infection is clearing up.

9

Do not throw away any medicines 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.
6. Contents of the pack and other information

8

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• Severe skin reactions such as erythema multiforme
(circular, irregular red patches), Stevens-Johnson
Syndrome (fever, hives, blisters or ulcers on your skin
or inside your mouth, nose, eyes and around your
genitals) or Toxic epidermal necrolysis (reddening,
peeling and swelling that resembles burns), severe
shedding of skin, rash or itching (especially affecting
the whole body)
• Fever, swollen lymph nodes or skin rash. These may be
symptoms of a condition known as DRESS (Drug rash
with eosinophilia and systemic symptoms) and can be
severe and life-threatening
• Severe headaches with changes in eyesight and
blurred or double vision, or loss of vision. Permanent
loss of vision has been reported
• Liver problems which can cause yellowing of skin and
whites of eyes, dark urine, pale stools

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Description Doxycycline 100 mg 90,60,30,28,56,84,25,250,50,21,20,8,7,5,14,100,10
Component Type Label Leaflet
Affiliate Item Code 991580
Superceded Affiliate Item Code 836398
TrackWise PR No. 991580
MA No. 04569/0035
Packing Site/Printer N/A
Supplier Code LL0448AG

Pharma Code 30
SAP No. N/A
Vendor Job No. 290894
Trackwise Proof No. 4
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info 5016695560090

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Primary and secondary syphilis: the recommended
dose is. 200 mg twice a day for 2 weeks.
Louse and tick-borne fevers: the recommended dose is
a single dose of 100 mg or 200 mg.
To treat malaria: (when chloroquine is not effective): the
recommended dose is 200 mg daily for at least 7 days.
Your doctor will also prescribe another medicine as well,
possibly quinine, to help treat the disease.
To prevent malaria: the recommended dose is 100 mg
daily starting 1 or 2 days before travelling to the malarial
area. Treatment should continue during your visit and for
4 weeks after leaving the area.
To prevent scrub typhus: the recommended dose is a
single dose of 200 mg
To prevent traveller’s diarrhoea: the recommended
dose is 200 mg as a single dose on the day of travel (or

Date: 01 Feb 2017
No. of colours
Colours
Non-Print
Colours

100 mg followed by a second dose of 100 mg 12 hours
later), then 100 mg daily throughout the stay (up to
3 weeks).
To prevent leptospirosis: the recommended dose is
200 mg once a week throughout the stay in the area and
200 mg on completion of the trip.
Use in children
Doxycycline must not be given to children under
12 years of age.
If you take more Doxycycline than you should
If you take more Doxycycline than you should contact your
doctor or hospital emergency department immediately.

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If you forget to take Doxycycline
If you forget to take a dose of Doxycycline take it as soon
as you remember unless it is nearly time for your next
dose. Never take two doses at the same time.

Time: 17:01

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Page Count
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306

Keyline

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PMS
283

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PMS
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Equate CMYK
with
Main Font Myriad Pro

Body Text Size 7 pt

Dimensions 52 x 101 mm

Min Text Size used 7 pt

Sign-offs

v2/Oct 2016

If you stop taking Doxycycline
Do not stop taking Doxycycline without talking to
your doctor first. It is important to finish the course of
antibiotic as instructed by your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If any of the following happen, stop taking Doxycycline
immediately and go to your nearest hospital
emergency department:
• Sudden wheeziness, difficulty breathing, chest pain,
sudden swellings, rash or itching (especially affecting
the whole body)

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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