CINNARIZINE 15MG TABLETS
Active substance(s): CINNARIZINE
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CINNARIZINE
15 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine.
This medicine is available without
prescription. However, you still need to take
Cinnarizine carefully to get the best results
from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• These tablets are only for you. Never give
them to anyone else.
• You must contact a doctor if your
symptoms worsen or do not improve after
2-3 days.
• 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.
IN THIS LEAFLET
1. What Cinnarizine is and what it is used for
2. Before you take Cinnarizine
3. How to take Cinnarizine
4. Possible side effects
5. How to store Cinnarizine
6. Further information
1
WHAT CINNARIZINE IS AND WHAT
IT IS USED FOR
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
If you see another doctor or visit a hospital,
remember to tell them what medicines you
are taking.
Children under five years of age should not
take Cinnarizine tablets.
If you take more Cinnarizine 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. An overdose is likely to
cause vomiting, drowsiness, coma,
(unconsciousness) tremor (shaking) or
hypotonia (floppy, relaxed state of muscles).
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.
Taking Cinnarizine with food and drink
Do NOT drink alcohol while you are taking
Cinnarizine tablets.
Pregnancy and breast-feeding
Cinnarizine is not recommended if you are
pregnant, planning to become pregnant or
breast-feeding. Ask your doctor for advice
before taking this medicine.
Important information about some of the
ingredients of Cinnarizine
Patients who are intolerant to lactose should
note that Cinnarizine tablets contain a small
amount of lactose. If you have been told by
your doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.
4
Take special care with Cinnarizine
Talk to your doctor or pharmacist before you
start to take Cinnarizine Tablets if you:
• suffer from Parkinson’s disease.
HOW TO TAKE CINNARIZINE
If your doctor or pharmacist has prescribed
this medicine, you should always take
Cinnarizine exactly as they have told you.
Otherwise, follow the instructions below.
If you are not sure how to take this medicine,
talk to your doctor or pharmacist.
If your symptoms persist after taking this
medicine, consult your doctor.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• tricyclic antidepressant medication, or any
other form of sedative.
If you need to have a skin test for allergies,
tell your doctor that you are taking
Cinnarizine tablets as these may affect the
result. You should stop taking your tablets at
REG0063723
least 4 days before you have the test.
HOW TO STORE CINNARIZINE
6
FURTHER INFORMATION
What Cinnarizine tablets contain:
• The active ingredient is cinnarizine 15 mg
• The other ingredients are lactose, starch,
povidone, isopropyl alcohol, magnesium
stearate, pregelatinised starch and colloidal
anhydrous silica (inactive ingredients).
What Cinnarizine tablets look like and
contents of the pack:
• Cinnarizine Tablets are white with “CNZ 15”
and a breakline on one side and a twin
triangle logo on the reverse.
• Cinnarizine Tablets come in a polypropylene
tubular container with an open end
If the following rare side effect happens, tell
equipped to accept a polyethylene closure
your doctor at once:
with a tamper evident tear strip containing
• uncontrollable movements and tremors
7, 10, 14, 22, 28, 30, 50, 56, 60, 84, 90, 100,
(extrapyramidal symptoms) may start or
112, 120, 250, or 1000 tablets.
become worse, particularly if you are
• PVDC coated PVC/Aluminium blisters
elderly and have been taking Cinnarizine
containing 7, 14, 21, 30, 50, 56, 60, 84,
tablets for a long time.
90,100, 112 or 120 tablets.
Not all pack sizes may be marketed.
The following side effects have been reported
at the approximate frequencies shown.
Marketing Authorisation Holder and
Manufacturer
Common:
Marketing Authorisation Holder is TEVA UK
• drowsiness or stomach upsets. These side
Limited, Eastbourne, BN22 9AG.
effects may disappear as your treatment
Company responsible for manufacture: Teva
continues.
Pharmaceutical Works Private Limited
Rarely:
Company, 4042 Debrecen, Pallagi út 13,
• headaches, dry mouth, you may put on
Hungary.
weight or sweat more than usual.
This leaflet was last revised June 2015.
Very rarely:
• an extremely itchy skin condition known as PL 00289/1440
lichen planus
• a condition which causes inflammation of
the skin known as lupus, which may also
affect your internal organs
• you may become jaundiced (where your
skin and the white of your eyes go slightly
yellow).
The usual dose is:
Ménière’s disease
• Adults including the elderly and children
over 12 years old
Two tablets three times a day unless
otherwise directed by your doctor.
• Children aged 5 to 12 years
Children aged 5 to 12 can take half the adult
dose (one tablet, three times a day) unless
otherwise directed by your doctor.
Travel sickness
• Adults (including the elderly) and children
over 12 years old
When Cinnarizine tablets are used to treat
travel sickness, the dose is two tablets two
hours before you travel then one tablet every
eight hours during the journey if necessary,
unless otherwise directed by your doctor.
• Children aged 5 to 12 years
Children aged 5 to 12 can take half the adult
dose (one tablet two hours before they
travel then half a tablet every eight hours
during
the journey
Version
1.6 if necessary, unless
otherwise directed by your doctor).
POSSIBLE SIDE EFFECTS
Like all medicines, Cinnarizine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the
tablets and tell your doctor immediately or go
to the casualty department at your nearest
hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
• Cinnarizine tablets belong to a group of
drugs known as antihistamines.
• Cinnarizine is used to:
• control travel sickness
• treat symptoms seen in Ménière’s
disease which include vertigo (a spinning
feeling), tinnitus (a ringing in your ears) The tablets should be swallowed preferably
with a drink of water.
and feeling or being sick.
Cinnarizine tablets can cause indigestion or
stomach upsets. Taking your tablets after food
2 BEFORE YOU TAKE CINNARIZINE
may help to reduce this.
Do NOT take Cinnarizine if you:
• are allergic (hypersensitive) to Cinnarizine
or any of the other ingredients of this
medicine
• have a hereditary metabolic disorder called
porphyria (a deficiency of specific enzymes
within the body, causing an increase in
substances called porphyrins).
5
Keep out of the reach and sight of children.
Store in a cool dry place, in the original
package. Do not use Cinnarizine after the
expiry date that is stated on the outer
If you forget to take Cinnarizine
If you forget to take a tablet, take one as soon packaging. The expiry date refers to the last
day of that month.
as you remember, unless it is nearly time to
take the next one. Do not take a double dose Medicines should not be disposed of via
wastewater or household waste. Ask your
to make up for a forgotten dose.
pharmacist how to dispose of medicines no
If you have any further questions on the use
longer required. These measures will help to
of this product, ask your doctor or
protect the environment.
pharmacist.
Driving and using machines
Cinnarizine may cause dizziness and
drowsiness. If affected do not drive or
operate machinery.
3
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.
Approved
Page 1 of 2
12006-C
160 x 280
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-00289-1440-cinnarizine-15mg-tablets
APPROVALS
Signed by
Madhavarao Thakallapally
REG0063723
Meaning of Signature
Regulatory Affairs Approval
Version 1.6
Approved
Server Date
12-Jun-2015 08:43:31 AM
Page 2 of 2
15 mg TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine.
This medicine is available without
prescription. However, you still need to take
Cinnarizine carefully to get the best results
from it.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advice.
• These tablets are only for you. Never give
them to anyone else.
• You must contact a doctor if your
symptoms worsen or do not improve after
2-3 days.
• 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.
IN THIS LEAFLET
1. What Cinnarizine is and what it is used for
2. Before you take Cinnarizine
3. How to take Cinnarizine
4. Possible side effects
5. How to store Cinnarizine
6. Further information
1
WHAT CINNARIZINE IS AND WHAT
IT IS USED FOR
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
If you see another doctor or visit a hospital,
remember to tell them what medicines you
are taking.
Children under five years of age should not
take Cinnarizine tablets.
If you take more Cinnarizine 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. An overdose is likely to
cause vomiting, drowsiness, coma,
(unconsciousness) tremor (shaking) or
hypotonia (floppy, relaxed state of muscles).
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.
Taking Cinnarizine with food and drink
Do NOT drink alcohol while you are taking
Cinnarizine tablets.
Pregnancy and breast-feeding
Cinnarizine is not recommended if you are
pregnant, planning to become pregnant or
breast-feeding. Ask your doctor for advice
before taking this medicine.
Important information about some of the
ingredients of Cinnarizine
Patients who are intolerant to lactose should
note that Cinnarizine tablets contain a small
amount of lactose. If you have been told by
your doctor that you have an intolerance to
some sugars, contact your doctor before
taking this medicinal product.
4
Take special care with Cinnarizine
Talk to your doctor or pharmacist before you
start to take Cinnarizine Tablets if you:
• suffer from Parkinson’s disease.
HOW TO TAKE CINNARIZINE
If your doctor or pharmacist has prescribed
this medicine, you should always take
Cinnarizine exactly as they have told you.
Otherwise, follow the instructions below.
If you are not sure how to take this medicine,
talk to your doctor or pharmacist.
If your symptoms persist after taking this
medicine, consult your doctor.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• tricyclic antidepressant medication, or any
other form of sedative.
If you need to have a skin test for allergies,
tell your doctor that you are taking
Cinnarizine tablets as these may affect the
result. You should stop taking your tablets at
REG0063723
least 4 days before you have the test.
HOW TO STORE CINNARIZINE
6
FURTHER INFORMATION
What Cinnarizine tablets contain:
• The active ingredient is cinnarizine 15 mg
• The other ingredients are lactose, starch,
povidone, isopropyl alcohol, magnesium
stearate, pregelatinised starch and colloidal
anhydrous silica (inactive ingredients).
What Cinnarizine tablets look like and
contents of the pack:
• Cinnarizine Tablets are white with “CNZ 15”
and a breakline on one side and a twin
triangle logo on the reverse.
• Cinnarizine Tablets come in a polypropylene
tubular container with an open end
If the following rare side effect happens, tell
equipped to accept a polyethylene closure
your doctor at once:
with a tamper evident tear strip containing
• uncontrollable movements and tremors
7, 10, 14, 22, 28, 30, 50, 56, 60, 84, 90, 100,
(extrapyramidal symptoms) may start or
112, 120, 250, or 1000 tablets.
become worse, particularly if you are
• PVDC coated PVC/Aluminium blisters
elderly and have been taking Cinnarizine
containing 7, 14, 21, 30, 50, 56, 60, 84,
tablets for a long time.
90,100, 112 or 120 tablets.
Not all pack sizes may be marketed.
The following side effects have been reported
at the approximate frequencies shown.
Marketing Authorisation Holder and
Manufacturer
Common:
Marketing Authorisation Holder is TEVA UK
• drowsiness or stomach upsets. These side
Limited, Eastbourne, BN22 9AG.
effects may disappear as your treatment
Company responsible for manufacture: Teva
continues.
Pharmaceutical Works Private Limited
Rarely:
Company, 4042 Debrecen, Pallagi út 13,
• headaches, dry mouth, you may put on
Hungary.
weight or sweat more than usual.
This leaflet was last revised June 2015.
Very rarely:
• an extremely itchy skin condition known as PL 00289/1440
lichen planus
• a condition which causes inflammation of
the skin known as lupus, which may also
affect your internal organs
• you may become jaundiced (where your
skin and the white of your eyes go slightly
yellow).
The usual dose is:
Ménière’s disease
• Adults including the elderly and children
over 12 years old
Two tablets three times a day unless
otherwise directed by your doctor.
• Children aged 5 to 12 years
Children aged 5 to 12 can take half the adult
dose (one tablet, three times a day) unless
otherwise directed by your doctor.
Travel sickness
• Adults (including the elderly) and children
over 12 years old
When Cinnarizine tablets are used to treat
travel sickness, the dose is two tablets two
hours before you travel then one tablet every
eight hours during the journey if necessary,
unless otherwise directed by your doctor.
• Children aged 5 to 12 years
Children aged 5 to 12 can take half the adult
dose (one tablet two hours before they
travel then half a tablet every eight hours
during
the journey
Version
1.6 if necessary, unless
otherwise directed by your doctor).
POSSIBLE SIDE EFFECTS
Like all medicines, Cinnarizine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the
tablets and tell your doctor immediately or go
to the casualty department at your nearest
hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect. You
may need urgent medical attention or
hospitalisation.
• Cinnarizine tablets belong to a group of
drugs known as antihistamines.
• Cinnarizine is used to:
• control travel sickness
• treat symptoms seen in Ménière’s
disease which include vertigo (a spinning
feeling), tinnitus (a ringing in your ears) The tablets should be swallowed preferably
with a drink of water.
and feeling or being sick.
Cinnarizine tablets can cause indigestion or
stomach upsets. Taking your tablets after food
2 BEFORE YOU TAKE CINNARIZINE
may help to reduce this.
Do NOT take Cinnarizine if you:
• are allergic (hypersensitive) to Cinnarizine
or any of the other ingredients of this
medicine
• have a hereditary metabolic disorder called
porphyria (a deficiency of specific enzymes
within the body, causing an increase in
substances called porphyrins).
5
Keep out of the reach and sight of children.
Store in a cool dry place, in the original
package. Do not use Cinnarizine after the
expiry date that is stated on the outer
If you forget to take Cinnarizine
If you forget to take a tablet, take one as soon packaging. The expiry date refers to the last
day of that month.
as you remember, unless it is nearly time to
take the next one. Do not take a double dose Medicines should not be disposed of via
wastewater or household waste. Ask your
to make up for a forgotten dose.
pharmacist how to dispose of medicines no
If you have any further questions on the use
longer required. These measures will help to
of this product, ask your doctor or
protect the environment.
pharmacist.
Driving and using machines
Cinnarizine may cause dizziness and
drowsiness. If affected do not drive or
operate machinery.
3
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.
Approved
Page 1 of 2
12006-C
160 x 280
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-00289-1440-cinnarizine-15mg-tablets
APPROVALS
Signed by
Madhavarao Thakallapally
REG0063723
Meaning of Signature
Regulatory Affairs Approval
Version 1.6
Approved
Server Date
12-Jun-2015 08:43:31 AM
Page 2 of 2
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
