GAVILAST 75MG TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

ASDA INDIGESTION
RELIEF TABLETS
(Ranitidine Hydrochloride)

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Ranitidine 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.
• You must contact a doctor if your symptoms
worsen or do not improve after 6 days.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ranitidine is and what it is used for
2. Before you take Ranitidine
3. How to take Ranitidine
4. Possible side effects
5. How to store Ranitidine
6. Further information
WHAT RANITIDINE IS AND WHAT IT IS
USED FOR
Ranitidine belongs to a group of medicines called H2
antagonists which works by reducing the amount of
acid in your stomach which helps in the short term
relief of acid related indigestion and heartburn.
BEFORE YOU TAKE RANITIDINE
Do not take Ranitidine
• If you are, or have ever been told you are allergic
to Ranitidine or to any of the other ingredients in
these tablets (an allergic reaction may include rash,
itching, swollen face or lips, or breathing
difficulties). See section 6 for a list of ingredients.
• If you are under 16 years of age.
Take special care with Ranitidine if:
• you have been diagnosed with or told you are at risk
from a duodenal (part of the small intestine) ulcer
• you are middle aged or older with new or recently
changed symptoms of indigestion
• you are suffering from any other illness or taking
medicines either prescribed by your doctor or have
been taking on your own
• you have unexplained weight loss or have
associated indigestion
• you are receiving medical attention for any reason
• you have kidney and or liver problems.
• you suffer from porphyria (excess protein in the urine)
If any of the above applies to you, please talk to your
doctor or pharmacist for advice if you have not
already done so before taking Ranitidine.

Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other medicines
including medicines obtained without a prescription.
This particularly applies to the following:
- If you are taking medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs)
such as aspirin or Ibuprofen (a pain relieving
medicine). This advice is even more important if
you are elderly
- Ketoconazole (an antifungal agent)
- Glipizide (a drug used to treat diabetes)
- Theophylline (used in the treatment of asthma)
- Sucralfate (an ulcer healing drug)
- Antacids (for your stomach)
- Procainamide (used to treat an irregular heart beat)
- Tolazoline (used to treat spasm of blood vessels
that supply blood to the hands and feet)

The usual doses of Ranitidine are:
Adults, the elderly and children over the age of
16 years:
Take one tablet whenever the symptoms of acidrelated indigestion and heartburn appear, day or night.
Do not take more than two tablets in 24 hours.
You should not take the tablets for more than 6 days
continuously. You should not purchase a second pack
of tablets without the advice of a pharmacist or doctor.
If you are unsure about how many tablets to take or
when to take them, ask your doctor or pharmacist.
Do not give these tablets to children under 16 years
of age.
Do not take any other medicine (including
non-prescription medicines) without first checking
with your doctor.

If you are taking antacids or Sucralfate (having
discussed this with your doctor) ensure that Asda
Indigestion Relief Tablets are taken at least two hours
before you take them.

If you take more Ranitidine than you should:
If you have taken too much Ranitidine, or if someone
else has taken your medicine, you / they should
contact your doctor or your nearest hospital casualty
department immediately. Please take any remaining
medicine with you in the carton in which it came so
that staff will know what has been taken.

Taking Ranitidine with food and drink:
Ranitidine should be swallowed whole with a glass of
water. You should not drink alcohol when taking this
medicine. The effects of alcohol may be increased by
taking Ranitidine.

If you forget to take Ranitidine
Take it as soon as you remember then continue as
before. If it is nearly time for your next tablet, leave
the missed dose and continue as before. Do not take
more than two tablets in 24 hours. Do not take a
double dose to make up for a missed dose.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Ranitidine should not be taken during pregnancy. If
you become pregnant while taking Ranitidine you
should talk to your doctor immediately.

If you have any further questions on the use of this
product, ask your doctor.

It is also not advised to take this medicine while
breast-feeding as Ranitidine passes into breast milk.

POSSIBLE SIDE EFFECTS

Driving or using machines:
There have been no reported effects on the ability to
drive or operate machinery. However, side effects like
severe dizziness, blurred vision and fatigue have
been reported in patients whilst on Ranitidine. It is
advisable to exercise caution when driving or
operating machinery. If you get these side effects, do
not drive or use machines or do anything else where
you need to be alert and concentrate.

Like all medicines, Ranitidine can have side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor immediately
if you experience any of the following rare effects:
• Sudden wheeziness or tightness in the chest or
throat, difficulty in breathing, speaking and swallowing.
• Itchy skin rash (hives) or swelling on the eyelids,
face, neck or lips
• Feeling faint.
These are all possible signs of a severe allergic reaction.

Important information about some of the
ingredients of Asda Indigestion Relief Tablets
This medicinal product contains 0.31mg of sodium
(salt) per dose. This should be taken into
consideration by patients on a controlled sodium
(salt) diet. The tablets also contain castor oil. This
may cause stomach upset and diarrhoea.

If you notice any of the following side effects,
tell your doctor immediately.
• Severe stomach pain, nausea, loss of appetite,
diarrhoea or constipation
• Unusual tiredness, shortness of breath, tendency to
bruising, unexplained fever or frequent interactions
• Slow or irregular heart beat
• Skin rash, itching or, jaundice (yellow skin or whites
of eyes)
• Depression, hallucinations, confusion or feeling
agitated
• Headache, dizziness, blurred vision

HOW TO TAKE RANITIDINE
Check the label to see how many tablets to take and
how often to take them. The tablets should be
swallowed whole with a glass of water.

Asda Indigestion Relief Tablets GSL
Black
Leaflet
4003177

Ranbaxy

05/04/12

TBC

1

TBC

N/A

N/A

N/A

N/A

130x170mm

DH

N/A

7039

Cutter

N/A

N/A

• Pain in muscles and joints
• In men swollen or tender breasts, difficulty in
achieving or maintaining an erection
There have been a few isolated reports of blood
abnormalities. This would only usually be seen after
you have had a blood test. Your doctor may perform
blood tests to check for abnormalities while you are
taking Ranitidine.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
HOW TO STORE RANITIDINE
Do not store above 25ºC. Store in the original
container to protect them from light.
Keep out of the reach and sight of children.
Do not use Ranitidine after the expiry date which is
stated on the blister and outer carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
FURTHER INFORMATION
What Asda Indigestion Relief Tablets contain
The active ingredient is: Ranitidine Hydrochloride
Each film-coated tablet contains 83.75mg of ranitidine
hydrochloride, equivalent to 75mg of ranitidine, as the
active ingredient.
The other ingredients are:
The tablets also contain some inactive ingredients:
microcrystalline cellulose, croscarmellose sodium,
colloidal anhydrous silica, magnesium stearate and talc.
Film-coating on the tablets contain: castor oil & Opadry
OY-S-54902 Pink which contains hypromellose, talc,
titanium dioxide (E171) and red ferric oxide (E172).
The Printing ink contains Opacode S-1-17823 Black
(containing shellac, Isopropyl alcohol, Iron oxide
black, N-Butyl alcohol, Propylene glycol and
Ammonium Hydroxide 28%).
What Asda Indigestion Relief Tablets look like
and contents of the pack
Asda Indigestion Relief Tablets are light pink, round,
biconvex, film coated tablets printed with “75” in
black edible ink on one side.
Asda Indigestion Relief Tablets are available in packs
containing 6, 10, 12, 20, 24 or 28 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Ranbaxy (UK) Limited,
Building 4, Chiswick Park, 566 Chiswick High Road,
London, W4 5YE, U.K.
Manufacturer: Ranbaxy Ireland Limited, Spafield,
Cork Road, Cashel, Co. Tipperary, Ireland.
Leaflet revision date: April 2012
4003177

0000000

PACKAGE LEAFLET:
INFORMATION FOR THE USER

ASDA INDIGESTION
RELIEF TABLETS
(Ranitidine Hydrochloride)

Read all of this leaflet carefully because it
contains important information for you.
This medicine is available without prescription.
However, you still need to take Ranitidine 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.
• You must contact a doctor if your symptoms
worsen or do not improve after 6 days.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ranitidine is and what it is used for
2. Before you take Ranitidine
3. How to take Ranitidine
4. Possible side effects
5. How to store Ranitidine
6. Further information
WHAT RANITIDINE IS AND WHAT IT IS
USED FOR
Ranitidine belongs to a group of medicines called H2
antagonists which works by reducing the amount of
acid in your stomach which helps in the short term
relief of acid related indigestion and heartburn.
BEFORE YOU TAKE RANITIDINE
Do not take Ranitidine
• If you are, or have ever been told you are allergic
to Ranitidine or to any of the other ingredients in
these tablets (an allergic reaction may include rash,
itching, swollen face or lips, or breathing
difficulties). See section 6 for a list of ingredients.
• If you are under 16 years of age.
Take special care with Ranitidine if:
• you have been diagnosed with or told you are at risk
from a duodenal (part of the small intestine) ulcer
• you are middle aged or older with new or recently
changed symptoms of indigestion
• you are suffering from any other illness or taking
medicines either prescribed by your doctor or have
been taking on your own
• you have unexplained weight loss or have
associated indigestion
• you are receiving medical attention for any reason
• you have kidney and or liver problems.
• you suffer from porphyria (excess protein in the urine)
If any of the above applies to you, please talk to your
doctor or pharmacist for advice if you have not
already done so before taking Ranitidine.

Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other medicines
including medicines obtained without a prescription.
This particularly applies to the following:
- If you are taking medicines known as
non-steroidal anti-inflammatory drugs (NSAIDs)
such as aspirin or Ibuprofen (a pain relieving
medicine). This advice is even more important if
you are elderly
- Ketoconazole (an antifungal agent)
- Glipizide (a drug used to treat diabetes)
- Theophylline (used in the treatment of asthma)
- Sucralfate (an ulcer healing drug)
- Antacids (for your stomach)
- Procainamide (used to treat an irregular heart beat)
- Tolazoline (used to treat spasm of blood vessels
that supply blood to the hands and feet)
If you are taking antacids or Sucralfate (having
discussed this with your doctor) ensure that Asda
Indigestion Relief Tablets are taken at least two hours
before you take them.
Taking Ranitidine with food and drink:
Ranitidine should be swallowed whole with a glass of
water. You should not drink alcohol when taking this
medicine. The effects of alcohol may be increased by
taking Ranitidine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Ranitidine should not be taken during pregnancy. If
you become pregnant while taking Ranitidine you
should talk to your doctor immediately.
It is also not advised to take this medicine while
breast-feeding as Ranitidine passes into breast milk.
Driving or using machines:
There have been no reported effects on the ability to
drive or operate machinery. However, side effects like
severe dizziness, blurred vision and fatigue have
been reported in patients whilst on Ranitidine. It is
advisable to exercise caution when driving or
operating machinery. If you get these side effects, do
not drive or use machines or do anything else where
you need to be alert and concentrate.
Important information about some of the
ingredients of Asda Indigestion Relief Tablets
This medicinal product contains 0.31mg of sodium
(salt) per dose. This should be taken into
consideration by patients on a controlled sodium
(salt) diet. The tablets also contain castor oil. This
may cause stomach upset and diarrhoea.
HOW TO TAKE RANITIDINE
Check the label to see how many tablets to take and
how often to take them. The tablets should be
swallowed whole with a glass of water.

The usual doses of Ranitidine are:
Adults, the elderly and children over the age of
16 years:
Take one tablet whenever the symptoms of acidrelated indigestion and heartburn appear, day or night.
Do not take more than two tablets in 24 hours.
You should not take the tablets for more than 6 days
continuously. You should not purchase a second pack
of tablets without the advice of a pharmacist or doctor.
If you are unsure about how many tablets to take or
when to take them, ask your doctor or pharmacist.
Do not give these tablets to children under 16 years
of age.
Do not take any other medicine (including
non-prescription medicines) without first checking
with your doctor.
If you take more Ranitidine than you should:
If you have taken too much Ranitidine, or if someone
else has taken your medicine, you / they should
contact your doctor or your nearest hospital casualty
department immediately. Please take any remaining
medicine with you in the carton in which it came so
that staff will know what has been taken.
If you forget to take Ranitidine
Take it as soon as you remember then continue as
before. If it is nearly time for your next tablet, leave
the missed dose and continue as before. Do not take
more than two tablets in 24 hours. Do not take a
double dose to make up for a missed dose.
If you have any further questions on the use of this
product, ask your doctor.
POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine can have side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor immediately
if you experience any of the following rare effects:
• Sudden wheeziness or tightness in the chest or
throat, difficulty in breathing, speaking and swallowing.
• Itchy skin rash (hives) or swelling on the eyelids,
face, neck or lips
• Feeling faint.
These are all possible signs of a severe allergic reaction.
If you notice any of the following side effects,
tell your doctor immediately.
• Severe stomach pain, nausea, loss of appetite,
diarrhoea or constipation
• Unusual tiredness, shortness of breath, tendency to
bruising, unexplained fever or frequent interactions
• Slow or irregular heart beat
• Skin rash, itching or, jaundice (yellow skin or whites
of eyes)
• Depression, hallucinations, confusion or feeling
agitated
• Headache, dizziness, blurred vision

• Pain in muscles and joints
• In men swollen or tender breasts, difficulty in
achieving or maintaining an erection
There have been a few isolated reports of blood
abnormalities. This would only usually be seen after
you have had a blood test. Your doctor may perform
blood tests to check for abnormalities while you are
taking Ranitidine.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
HOW TO STORE RANITIDINE
Do not store above 25ºC. Store in the original
container to protect them from light.
Keep out of the reach and sight of children.
Do not use Ranitidine after the expiry date which is
stated on the blister and outer carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
FURTHER INFORMATION
What Asda Indigestion Relief Tablets contain
The active ingredient is: Ranitidine Hydrochloride
Each film-coated tablet contains 83.75mg of ranitidine
hydrochloride, equivalent to 75mg of ranitidine, as the
active ingredient.
The other ingredients are:
The tablets also contain some inactive ingredients:
microcrystalline cellulose, croscarmellose sodium,
colloidal anhydrous silica, magnesium stearate and talc.
Film-coating on the tablets contain: castor oil & Opadry
OY-S-54902 Pink which contains hypromellose, talc,
titanium dioxide (E171) and red ferric oxide (E172).
The Printing ink contains Opacode S-1-17823 Black
(containing shellac, Isopropyl alcohol, Iron oxide
black, N-Butyl alcohol, Propylene glycol and
Ammonium Hydroxide 28%).
What Asda Indigestion Relief Tablets look like
and contents of the pack
Asda Indigestion Relief Tablets are light pink, round,
biconvex, film coated tablets printed with “75” in
black edible ink on one side.
Asda Indigestion Relief Tablets are available in packs
containing 6, 10, 12, 20, 24 or 28 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Ranbaxy (UK) Limited,
Building 4, Chiswick Park, 566 Chiswick High Road,
London, W4 5YE, U.K.
Manufacturer: Ranbaxy Ireland Limited, Spafield,
Cork Road, Cashel, Co. Tipperary, Ireland.
Leaflet revision date: April 2012
4003177

0000000

Expand view ⇕

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.

Hide
(web5)