new proposed PL

Transcription

new proposed PL

Ticlopidine hydrochloride; DE/H/0203/001/R/002; 01.02.1304.08.11-corr.
For matier t: Zeilenabstand: einfach
new proposed PL
For matier t: Schriftart: 18 P t., N icht
unterstrichen, Englisch
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PACKAGE LEAFLET: INFORMATION FOR THE USERPackage Leaflet: Information for
the patient
For matier t: Rechtschreibung und
G rammatik prüfen
/…/
Ticlopidine hydrochloride
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 only. Do not pass it on to others. It may harm them,
even if their symptomssigns of illness are the same as yours.
If you get any of the side effects gets serious,, talk to your doctor or if you notice any
pharmacist. This includes any possible side effects not listed in this leaflet, please tell your
doctor or pharmacist.
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In
What is in this leaflet:
1.
What /…/ is and what it is used for
2.
BeforeWhat you need to know before you take /…/
3.
How to take /…/
4.
Possible side effects
5.
How to store /…/
6.
FurtherContents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FORWhat /…/ is and what it is used for
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/…/ belongs to a group of medicines called antiplatelet agents, which help to prevent blood clots.
/…/ is used to help prevent strokes in patients who have previously had a stroke or in those who are
considered to be at risk of having a stroke. It is also used to help prevent blood clots in patients
undergoing haemodialysis.
2.
BEFORE YOU TAKE /…/
2.
What you need to know before you take /…/
Do not take /…/
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Ifif you are allergic (hypersensitive) to ticlopidine hydrochloride or any of the other ingredients
in your of this medicine (listed in section 6)
Ifif you have very recently had a stroke
Ifif you have organic lesions which are liable to bleed such as a stomach or intestinal ulcer or
bleeding in the brain
Ifif you have a serious bleeding disorder
Ifif you have or have ever had abnormal results from blood tests, such as a low white cell or
platelet count.
Warnings and precautions
Talk to your doctor or pharmacist before taking /…/.
For matier t: Rechtschreibung und
G rammatik prüfen, N icht
G roßbuchstaben
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For matier t: Keine A ufzählungen oder
N ummerierungen
new proposed PL
(G roßbritannien)
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Take special care with /…/
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
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Ifif you have liver problems
Ifif you have kidney problems
if you have a bleeding or blood clotting disorder
if you have any surgery (including at the dentist).
if you take medicines such as aspirin, heparin, non-steroidal anti-inflammatory drugs (NSAIDs)
e.g. ibuprofen, or anticoagulants e.g. warfarin due to the increased risk of bleedings during the
concomitant use with /…/.
For planned surgery be sure to tell your doctor well in advance as he or she may recommend you stop
taking your tablets temporarily.
If you have emergency surgery make sure you tell the doctor or dentist you are taking /…/.
Your doctor will carry out routine blood tests to check your blood chemistry. These will usually be
every two weeks during the first three months of treatment, and two weeks after stopping treatment if
this is within the first three months.
You should stop taking /…/ and contact your doctor immediately if you develop persistent
unexplained fever, sore throat or mouth ulcers, prolonged or unusual bleeding, bruising, a purple rash
or , tarry stools or neurological symptoms such as hallucinations, bizarre behavior, altered mental
status, stroke-like symptoms, headaches or kidney problems. Your doctor will order a blood test and
decide whether or not you may start taking /…/ again.
Please tell your doctor if you have kidney problems. He may want to monitor you more closely.
Contact your doctor if you develop signs of liver inflammation (hepatitis) such as jaundice (yellowing
of the skin and whites of the eyes), light-coloured stools, dark urine.
Taking otherChildren and adolescents
The use of /…/ in children and adolescents is not recommended.
Other medicines and /…/
Talk to your doctor or pharmacist if you are taking any of the following:
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Medicines which increase the risk of bleeding, such as aspirin, heparin, non-steroidal antiinflammatory drugs (NSAIDs) e.g. ibuprofen, or anticoagulants e.g. warfarin.
Cimetidine (an anti-ulcer drug), as this increases the amount of ticlopidine hydrochloride in the
blood
Theophylline (for breathing problems), sedatives, sleeping pills or phenazone (an NSAID) as
these drugs may remain in the body for longer than usual and your doctor may need to adjust
your dose
Antacids (for indigestion), as the effectiveness of ticlopidine hydrochloride may be reduced
Ciclosporin (used following organ transplant), as the effectiveness of the ciclosporin may be
reduced and your dose of ciclosporin may need to be adjusted
Digoxin (for heart problems), as there may be a slight decrease in the amount of digoxin in the
blood
Phenytoin (for epilepsy), as the amount of phenytoin in the blood may vary from usual.
Please tellTell your doctor or pharmacist if you are taking or /using, have recently taken/used or might
take/use any other medicines, including medicines obtained without a prescription.
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Taking /…/ with food and drink

Take your tablets during a meal so that you are less likely to feel s ick or have diarrhoea.
N ummerierungen
Pregnancy and breast-feeding

Do not take /…/ if you are pregnant or breast-feeding.
N ummerierungen
Driving and using machines
/…/The side effects of /…/, such as dizziness, may affect your ability to drive and use machines,
especially if taken with alcohol.

3.
3.
HOW TO TAKE /…/
How to take /…/
Always take /…/this medicine exactly as your doctor or pharmacist has told you. You should
checkCheck with your doctor or pharmacist if you are not sure.
N ummerierungen
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The tablets should be swallowed with a drink of water (after half the meanmeal has been taken).
The usualrecommended dose is:
Adults:
Take one tablet, twice a day.
Do not take more than two tablets in one day.
ChildrenUse in children and adolescents:
The use in children and adolescents is not recommended .
If you take more /…/ than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which tablets were consumed. Overdose may cause prolonged bleeding and severe
stomach problems.
If you forget to take /…/
If you forget to take a tablet, 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 missedforgotten dose.
If you stop taking /…/
Do not stop taking /…/ without consulting your doctor. It is important to continue taking this medicine
even if you feel well.
If you have any further questions on the use of this productmedicine, ask your doctor or pharmacist.
4.POSSIBLE SIDE EFFECTS
4.
Possible side effects
Like all medicines, /…/this medicine can cause side effects, although not everybody gets them.
The following frequency categories are used in the evaluation of If you get any side effects:
For matier t: Schriftart: N icht Kursiv
For matier t: Schriftart: N icht Kursiv
For matier t: Links, Keine
A ufzählungen oder N ummerierungen,
V om nächsten A bsatz trennen
(G roßbritannien)
new proposed PL
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very
common
common
uncomm
on
rare
very rare
not
known
affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data
Tell, talk to your doctor if you notice any of the symptoms listed below:or pharmacist. This includes
any side effects not listed in this leaflet.
Blood and blood vessel problems
Common: (may affect up to 1 in 10 users)

Blood disorders (which may be characterised by fever or chills, sore throat, ulcers in the mouth
or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruising)
For matier t: Schriftart: Kursiv

H ängend: 1 cm, Rechts: 0 cm,
A ufgezählt + Ebene: 1 + A usgerichtet
an: 1 cm + Tabstopp nach: 1,63 cm
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. If blood disorders do occur this is most likely during the first three months of treatment.
Uncommon (may affect up to 1 in 100 users)

Reduction in blood platelets (thrombocytopenia), which increases the risk of bruising and
bleeding
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An abnormal breakdown of red blood cells (haemolytic anaemia)

An infection in the blood (sepsis), which can cause fever or chills, rapid heartbeat or rapid
breathing; and septic shock (a life-threatening form of sepsis which can lead to multiple organ
failure) due to a reduction of a certain type of white blood cells (agranulocytosis)

Bleeding or bruising under the skin, nosebleeds

Bleeding in the eye, blood in the urine
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An increased risk of bleeding during or after operations
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Severe bleedings.
Rare: (may affect up to 1 in 1,000 users)
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A drop in the number of red and white blood cells and platelets (pancytopenia), a failure of the
bone marrow to produce new blood cells
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A potentially life-threatening disorder called thrombotic-thrombocytopenic purpura.
The symptoms of this are unusual bleeding or unexplained bruising, anaemia or jaundice, fever,
stroke-like symptoms, kidney problems.
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Frequency not known:
Bruising, nosebleeds
Blood in the urine, bleedingLeukaemia
Higher than normal platelet count (thrombocytosis)
Bleeding in the brain.
Not known (frequency cannot be estimated from the available data)

Bleeding into the stomach or intestine.

An increased risk of bleeding during or after operations.
Other side effects
(G roßbritannien)
new proposed PL
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Common (may affect up to 1 in 10 users)

Dizziness, headache

Digestive disturbances such as feeling sick, vomiting and diarrhoea. These mostly occur during
the first three months of treatment but usually wear off within a few days

Increase in liver enzymes

Allergic skin reactions such as itching or rash (including hives). If skin reactions do occur this is
most likely within the first three months of treatment

Long term treatment may cause an increase in blood fat levels (e.g. cholesterol and
triglycerides), although this does not appear to affect the risk of heart or blood vessel problems.
Other side effects

Common:
Digestive disturbances such as feeling sick, vomiting and diarrhoea. These mostly occur during
the first three months of treatment but usually wear off within a few days.
Uncommon: (may affect up to 1 in 100 users)
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Dizziness, headache, general aches and pains
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Tiredness
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Loss of appetite.
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Rare:
Hepatitis (inflammation of the liver)
Jaundice (yellowing of the skin and whites of the eyes)
Increase in liver enzymes
Generally feeling unwell
Tingling, numbness or one-sided weakness (sensory disturbances)
Ulcers in the stomach or upper part of the intestine
Increase in bilirubin
Inflammation and peeling of the skin (exfoliative dermatitis)
Feeling weak and tired (asthenia), general aches and pains.
Rare (may affect up to 1 in 1,000 users)

Depression, nervousness, difficulty sleeping

Ringing in the ears
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Palpitations, light-headedness, nervousness, difficulty sleeping, sweating
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Changes in the sense of taste
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Depression, altered perception
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Very rare:
Severe skin rash
Blistering of the lips, eyes, nose, mouth and genitals
Severe diarrhoea with colitis (inflammation of the intestine), fatal liver function disorders
Irregular heartbeat (palpitations)
Inflammation of the liver (hepatitis) and yellowing of the skin and whites of the eyes (jaundice)
in the first months of treatment
Generally feeling unwell
Sweating.
Very rare (may affect up to 1 in 10,000 users)

Reactions of the immune system such as Quincke’s oedema (pain and swelling of the skin),
vasculitis ( (Quincke oedema), inflammation of the blood vessels), lupus erythematosus (
(vasculitis), increase in a type of white blood cells (eosinophilia), a disease affecting the skin
and joints) and (lupus erythematosus), allergic inflammation of the kidney problemssometimes
resulting in renal failure, joint pain, allergic lung disease, anaphylactic shock (a severe
H ängend: 1 cm, Rechts: 0 cm,
A ufgezählt + Ebene: 1 + A usgerichtet
an: 1 cm + Tabstopp nach: 1,63 cm
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N icht an 1,63 cm
For matier t: Rechts: 0 cm
(G roßbritannien)
new proposed PL
Page 6 / 7



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hypersensitivity reaction with difficulty breathing, hives, itching and swelling (anaphylactic
shock)
Fever
Frequency not known:
Allergic skin reactions such as itching or rash (including hives)
Severe diarrhoea with inflammation of the intestine (colitis)
Fatal liver function disorders
Sudden, severe inflammation of the liver (fulminant hepatitis)

If any of the side effects gets serious or if you notice any side effects not mentioned in Severe
form of skin rash (Erythema multiforme) with flushing, fever, blisters or ulcers (StevensJohnson syndrome), severe rash involving reddening, peeling and swelling of the skin that
resembles severe burns (Lyell syndrome)
Fever.
5.
How to store /.../
Keep this leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE /.../
For matier t: Schriftart: N icht Kursiv ,
Rechtschreibung und G rammatik
prüfen
Keep medicine out of the sight and reach and sight of children.
Do not use /.../this medicine after the expiry date which is stated on the label and the carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
6.
FURTHER INFORMATION
6.
Contents of the pack and other information
What /.../ contains
-
For matier t: Schriftart: F ett, N icht
unterstrichen
The active substance is ticlopidine hydrochloride.
Each film-coated tablet contains 250 mg ticlopidine hydrochloride.
For matier t: Einzug: Erste Zeile: 1 cm
The other ingredients are macrogol 6000, titanium dioxide (E 171), hypromellose, povidone
KK 25, microcrystalline cellulose, maize starch, magnesium stearate, colloidal silicon dioxide.
H ängend: 1 cm
What /.../ looks like and contents of the pack
unterstrichen
White to off-white, slightly convex film-coated tablet.
/.../ is available in pack sizes of 10, 20, 30, 60, 90 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
unterstrichen
[To be completed nationally]
For matier t: Schriftartfarbe:
A utomatisch
This medicinal product is authorised in the Member States of the EEA under the following
names:
(G roßbritannien)
new proposed PL
Page 7 / 7
Belgium:
Germany:
Portugal:
Ticlopidin-ratiopharm® 250 mg, comprimés pelliculés
Ticlopidin-ratiopharm®
Ticlopidina ratiopharm 250 mg comprimidos revestidos
This leaflet was last approvedrevised in
{MM/ {month YYYY}.
[To be completed nationally]
For matier t: Schriftartfarbe:
A utomatisch

new proposed PL

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