Tramadol H Cl/Para cetamol 37.

5 mg/32 5 mg Film Coated Ta blets, Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Trama dol HCl /Paraceta mol Dosage & Rx I nfo | Tramadol HCl/Para cetamol Uses, Side Effects – A ntifungal/ Antibacterial, Tra madol H Cl/Para cetamol 37.5 mg/325 mg Film Coated Tabl ets: Indications, Side Effe cts, Warni ngs, Trama dol H Cl/Paracetamol - Drug Infor mation - Taj Phar ma, Trama dol HCl /Paraceta mol dose Taj phar maceuticals Tra madol HCl/ Paraceta mol interactions, Taj Phar ma ceutical Tra madol H Cl/Para cetamol contraindications, Tra madol H Cl/Para cetamol price, Tra madol H Cl/Para cetamol , Taj Pharma Tra madol HCl/Para cetamol 37.5 mg/3 25 mg Film Coate d Tablets, - Taj Phar ma . Stay conne cted to all updated on Tra madol H Cl/Para cetamol Taj Pharma ceuti cals Taj phar ma ceuticals Hyderabad. Patient Infor mation Leaflets, PIL.

1. What Tramadol HCl/Paracetamol is

TRAMADOL/ and what it is used for
jaundice or problems with bile ducts
• have difficulty breathing, for example,
PARACETAMOL FILM Tramadol/Paracetamol is a combination of
two analgesics (pain killers) tramadol and
asthma or lung problems
• are dependent on any other medicines
COATED TABLETS paracetamol that act together to relieve used to relieve moderate to severe pain, for
example, morphine
your pain. Tramadol/Paracetamol is
37.5 MG/325 MG intended for use in the treatment of • are epileptic or if have you experienced fits
moderate to severe pain when your doctor or seizures
Package leaflet: Information for the recommends that a combination of • have suffered from a head injury, shock or
patient tramadol and paracetamol is needed. severe headaches which may or may not be
Tramadol/Paractamol 37.4mg/325mg Film associated with vomiting
Coated Tablets. 2. Before you are given Tramadol • take other medicines containing
HCl/Paracetamol paracetamol or tramadol.
Read all of this leaflet carefully before you Do not take Tramadol/Paracetamol if you:
start taking this medicine because it • are allergic to paracetamol, tramadol or Other medicines and
contains important information for you. any of the other ingredients of this medicine Tramadol/Paracetamol
- Keep this leaflet. You may need to read it (listed in section 6) Tell your doctor or pharmacist if you are
again. • drink alcohol taking, have recently taken or might take
- If you have any further questions, ask your • take any medicine that can make you any other medicines.
doctor or pharmacist. sleepy or less alert; these include opioids • Important: This medicine contains
- This medicine has been prescribed for you containing pain relievers such as morphine paracetamol and tramadol. Tell your
only. Do not pass it on to others. It may and codeine doctor if you are taking any other
harm them, even if their signs of illness are • are also taking MAO inhibitors (certain medicine containing paracetamol or
the same as yours. medicines used for treatment of depression tramadol, so that you do not exceed the
- If any of the side effects gets serious, or if or Parkinson’s disease) or have taken them maximum daily doses.
you notice any side effects not listed in this in the last 14 days before treatment with • You must not take Tramadol/Paracetamol
leaflet, please tell your doctor. Tramadol/Paracetamol together with monoamine oxidase
• suffer from severe liver problems inhibitors (“MAOIs”) (see section “Do not
• have epilepsy that is not adequately take Tramadol/Paracetamol”).
What is in this leaflet
controlled on your current medicine.
Tramadol/Paracetamol is not
1. What Tramadol HCl/Paracetamol is and recommended with the following
what it is used for Warnings and precautions
Talk to your doctor or pharmacist before medicines, as it may affect how well they
2. Before you are given Tramadol work:
HCl/Paracetamol taking Tramadol/Paracetamol.
Take special care with • carbamazepine (a medicine used to treat
3. How you will be given Tramadol epilepsy or some types of pain)
HCl/Paracetamol Tramadol/Paracetamol if you:
• have kidney problems • buprenorphine, nalbuphine or pentazocine
4. Possible side effects (opioid-type pain relievers). The pain-
5. How Tramadol HCl/Paracetamol is stored • have liver problems or alcoholic liver
disease or you have noticed your eyes and relieving effect may be reduced.
6. Further Information
skin turning yellow, which may suggest
Tramadol H Cl/Para cetamol 37.5 mg/32 5 mg Film Coated Ta blets, Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Trama dol HCl /Paraceta mol Dosage & Rx I nfo | Tramadol HCl/Para cetamol Uses, Side Effects – A ntifungal/ Antibacterial, Tra madol H Cl/Para cetamol 37.5 mg/325 mg Film Coated Tabl ets: Indications, Side Effe cts, Warni ngs, Trama dol H Cl/Paracetamol - Drug Infor mation - Taj Phar ma, Trama dol HCl /Paraceta mol dose Taj phar maceuticals Tra madol HCl/ Paraceta mol interactions, Taj Phar ma ceutical Tra madol H Cl/Para cetamol contraindications, Tra madol H Cl/Para cetamol price, Tra madol H Cl/Para cetamol , Taj Pharma Tra madol HCl/Para cetamol 37.5 mg/3 25 mg Film Coate d Tablets, - Taj Phar ma . Stay conne cted to all updated on Tra madol H Cl/Para cetamol Taj Pharma ceuti cals Taj phar ma ceuticals Hyderabad. Patient Infor mation Leaflets, PIL.

Tramadol/Paracetamol may increase the Tramadol/Paracetamol can be taken with or Always take this medicine exactly as your
risk of side effects if you also take the without food. doctor has told you. Check with your doctor
following medicines: • Tramadol/Paracetamol may make you feel or pharmacist if you are not sure.
• triptans (used for migraine) or selective drowsy. Alcohol may make you feel
serotonin re-uptake inhibitors (SSRIs, used drowsier. Alcohol: increases the sedative The usual starting dose is two tablets. If
for depression). Check with your doctor if effect of opioid analgesics, the effect on required, further doses can be taken after
you experience confusion, restlessness, alertness can make driving of vehicles and every six hours, as recommended by your
fever, sweating, uncoordinated movement the use of machines dangerous, avoid intake doctor.
of limbs or eyes, uncontrollable jerking of of alcoholic drinks and of medicinal Do not take more than 8 tablets per day
muscles or diarrhoea. products containing alcohol. (equivalent to 300 mg tramadol
• tranquilizers, sleeping pills, other pain hydrochloride and 2600 mg paracetamol).
relievers such as morphine and codeine Pregnancy and breast-feeding The dosage should be adjusted to the
(also as cough medicine), baclofen (a muscle If you are pregnant or breast-feeding, think intensity of your pain and your individual
relaxant), medicines used to lower blood you may be pregnant or are planning to pain sensitivity. In general the lowest pain-
pressure, antidepressants or medicines to have a baby, ask your doctor or pharmacist relieving dose should be taken.
treat allergies. Check with your doctor if you for advice before taking this medicine.
feel drowsy or feel faint. Severe liver disease (insufficiency)
• antidepressants, anaesthetics, medicines Pregnancy Patients with severe liver insufficiency
that affect the state of mind, or bupropion Since Tramadol/Paracetamol is a fixed should not take Tramadol hydrochloride
(used to help stop smoking). The risk of combination of active ingredients including /Paracetamol. If in your case the
having a fit may increase. Your doctor will tramadol, it should not be used during insufficiency is mild or moderate, your
tell you whether Tramadol/Paracetamol is pregnancy. doctor may recommend prolonging the
suitable for you. dosage interval.
• warfarin or phenprocoumon (for blood Breast-feeding
thinning). The effectiveness of such Tramadol is excreted into breast milk. For Use in children
medicines may be altered and bleeding may this reason, you should not take Tramadol/Paracetamol is not recommended
occur (see section 4). Tramadol/Paracetamol more than once for use in children under 12 years.
during breast-feeding, or alternatively, if you
The effectiveness of take Tramadol/Paracetamol more than once, Elderly patients
Tramadol/Paracetamol may be altered if you should stop breast-feeding. In elderly patients (above 75 years) the
you also take the following medicines: excretion of tramadol may be delayed. If this
• metoclopramide, domperidone or Driving and using machines applies to you, your doctor may recommend
ondansetron (medicines used to treat Do not drive, operate machinery or perform prolonging the dosage interval.
nausea and vomiting/being sick) other activities for which you need to be
alert until you know how The tablets must be swallowed with some
• cholestyramine (medicine used to reduce
Tramadol/Paracetamol affects you. liquid. The tablets should not be chewed or
cholesterol in the blood)
Tramadol/Paracetamol may make you feel crushed. The tablets should be taken for as
• ketoconazole or erythromycin (medicines
drowsy. short a time as possible. If you think that the
used against infections).
effect of Tramadol/Paracetamol is too
Tramadol/Paracetamol with food, drink 3. How you will be given Tramadol strong (i.e. you feel very drowsy or have
and alcohol HCl/Paracetamol difficulty with breathing) or too weak (i.e.
Tramadol H Cl/Para cetamol 37.5 mg/32 5 mg Film Coated Ta blets, Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Trama dol HCl /Paraceta mol Dosage & Rx I nfo | Tramadol HCl/Para cetamol Uses, Side Effects – A ntifungal/ Antibacterial, Tra madol H Cl/Para cetamol 37.5 mg/325 mg Film Coated Tabl ets: Indications, Side Effe cts, Warni ngs, Trama dol H Cl/Paracetamol - Drug Infor mation - Taj Phar ma, Trama dol HCl /Paraceta mol dose Taj phar maceuticals Tra madol HCl/ Paraceta mol interactions, Taj Phar ma ceutical Tra madol H Cl/Para cetamol contraindications, Tra madol H Cl/Para cetamol price, Tra madol H Cl/Para cetamol , Taj Pharma Tra madol HCl/Para cetamol 37.5 mg/3 25 mg Film Coate d Tablets, - Taj Phar ma . Stay conne cted to all updated on Tra madol H Cl/Para cetamol Taj Pharma ceuti cals Taj phar ma ceuticals Hyderabad. Patient Infor mation Leaflets, PIL.

you have inadequate pain relief), contact side effects, although not everybody gets • blood in the stools,
your doctor or pharmacist. If your symptoms them. • shivering,
do not get any better, see your doctor. • hot flushes,
The very common side effects (may affect • pain in the chest,
If you take more Tramadol/Paracetamol more than 1 in 10 people): • involuntary muscle twitching,
than you should • nausea, • unusual tingling feeling (“pins and
Immediate medical advice should be sought • dizziness, needles”),
in the event of an overdose, even if you feel • drowsiness. • shortness of breath,
well, because of the risk of delayed, serious These are usually mild and not troublesome. • raised liver enzymes.
liver damage. If you take more
Tramadol/Paracetamol than you should you Common side effects (may affect up to 1 Rare side effects (may affect up to 1 in
could experience severe disturbance of in 10 people): 1,000 people) :
blood supply to organs, consciousness • vomiting, • drug dependence,
disorders up to coma, convulsions, or you • digestion problems (constipation, • fits, difficulties in carrying out coordinated
might have difficulty breathing, feel unwell, flatulence, diarrhoea), movements,
vomit, lose weight or feel abdominal pain. • stomach pain, • blurred vision,
• dry mouth, • transient loss of consciousness.
If you forget to take • headache,
Tramadol/Paracetamol • shaking, Very rare side effect (may affect up to 1 in
Do not take a double dose to make up for a • confusion, 10,000 people):
forgotten tablet. If you miss a dose of • sleep disorders, • drug abuse.
Tramadol/Paracetamol, take your next • mood changes (anxiety, nervousness,
tablet at the usual time. euphoria (a sense of feeling “high” all the Unknown side effect (frequency cannot
time)), be estimated from the available data):
If you stop taking Tramadol/Paracetamol • increased sweating, • decrease in blood sugar level.
If you have been using • itching.
Tramadol/Paracetamol for some time, you The following are recognised side effects
should talk to your doctor if you want to Uncommon side effects (may affect up to which have been reported by people using
stop because your body may have got used 1 in 100 people): medicines that contain only tramadol
to it. If you do suddenly stop using • high blood pressure, heart rhythm and hydrochloride or paracetamol. However, if
Tramadol/ Paracetamol you may feel unwell. heart rate disorders, you experience any of these while taking
You may experience anxiety, agitation, • difficulty or pain on passing urine, protein Tramadol/Paracetamol, you should tell your
nervousness, sleeplessness, hyperactivity, in the urine, doctor:
tremors and/or an upset stomach. • skin reactions (hives, rashes) • feeling faint when getting up from a lying
• ringing in the ear, or sitting position, slow heart rate, fainting,
If you have any further questions on the use • depression, changes in appetite, muscle weakness,
of this medicine, ask your doctor or • nightmares, slower or weaker breating, mood changes,
pharmacist. • hallucinations (hearing, seeing or sensing changes in activitiy, changes in perception,
things that are not really there), worsening of asthma.
4. Possible Side Effects • loss of memory, • in some rare cases a skin rash, indicating an
Like all medicines, this medicine can cause • difficulty swallowing, allergic reaction, may develop with sudden
Tramadol H Cl/Para cetamol 37.5 mg/32 5 mg Film Coated Ta blets, Taj Phar ma : Us es, Side E ffe cts, Intera ctions, Picture s, Warning s, Trama dol HCl /Paraceta mol Dosage & Rx I nfo | Tramadol HCl/Para cetamol Uses, Side Effects – A ntifungal/ Antibacterial, Tra madol H Cl/Para cetamol 37.5 mg/325 mg Film Coated Tabl ets: Indications, Side Effe cts, Warni ngs, Trama dol H Cl/Paracetamol - Drug Infor mation - Taj Phar ma, Trama dol HCl /Paraceta mol dose Taj phar maceuticals Tra madol HCl/ Paraceta mol interactions, Taj Phar ma ceutical Tra madol H Cl/Para cetamol contraindications, Tra madol H Cl/Para cetamol price, Tra madol H Cl/Para cetamol , Taj Pharma Tra madol HCl/Para cetamol 37.5 mg/3 25 mg Film Coate d Tablets, - Taj Phar ma . Stay conne cted to all updated on Tra madol H Cl/Para cetamol Taj Pharma ceuti cals Taj phar ma ceuticals Hyderabad. Patient Infor mation Leaflets, PIL.

swelling of the face and neck, difficulties possible side effects not listed in this leaflet. What Tramadol HCl/Paracetamol looks
breathing or drop of blood pressure and By reporting side effects you can help like and contents of the pack
fainting. If this happens to you, stop provide more information on the safety of Film-coated tablets are yellow-brown, oval,
treatment and see a doctor immediately. this medicine. slightly biconvex.
You must not take the medicine again. Boxes of 2 film-coated tablets (blisters with 2
5. How Tramadol HCl/Paracetamol is tablets) or 10, 20, 30, 40, 50, 60, 70, 80, 90
In rare cases, using a medicine of the type of stored and 100 film-coated tablets (blisters with 10
tramadol may make you become Keep this medicine out of the sight and tablets) are available.
dependent on it, making it hard to stop reach of children. Not all pack sizes may be marketed.
taking it.
On rare occasions, people who have been Do not use this medicine after the expiry
taking tramadol for some time may feel date which is stated on the packaging after
unwell if they stop treatment abruptly. They EXP. The expiry date refers to the last day of
may feel agitated, anxious, nervous or shaky. that month.
They may be hyperactive, have difficulty Manufactured in India by:
sleeping and have stomach or bowel This medicine does not require any special TAJ PHARMACEUTICALS LTD.
disorders. Very few people may also get storage conditions. Mumbai, India
panic attacks, hallucinations, unusual At: 615, GIDC, Kerala, Bavla, Dist.
perception such as itching, tingling, Do not throw away any medicines via Ahmedabad 438225, Gujarat, INDIA
numbness and ringing in the ears (tinnitus). wastewater or household waste. Ask your
pharmacist how to throw away medicines This leaflet was last revised in August 2019
If you do notice any of these effects, or any
other unusual symptoms, please tell your you no longer use. These measures will help
doctor or pharmacist as soon as possible. protect the environment.
In exceptional cases blood tests may reveal
certain abnormalities, for instance, low 6. Further information
counts of blood platelets, which may result
in nose bleeds or bleeding gums. What Tramadol HCl/Paracetamol contains
Very rare cases of serious skin reactions have • The active substances are tramadol
been reported for paracetamol containing hydrochloride and paracetamol. Each film-
medicines. coated tablet contains 37.5 mg mg tramadol
hydrochloride equivalent to 32.94 mg
Use of Tramadol/Paracetamol together with tramadol and 325 mg paracetamol.
medicines used to thin the blood (e.g. • The other ingredients are:
phenoprocoumon, warfarin) may increase – Tablet core: pregelatinised maize starch,
the bleeding risk. Any prolonged or sodium starch glycolate (type A),
unexpected bleeding should be reported to microcrystalline cellulose (E460) and
your doctor immediately. magnesium stearate (E572).
– Film-coating: hypromellose, titanium
Reporting of side effects dioxide (E171), macrogol 400, yellow iron
If you get any side effects, talk to your oxide (E172) and polysorbate 80.
doctor or pharmacist. This includes any