Gripex control

Patient Information Leaflet

Gripex Control, 500 mg + 50 mg, tablets
Paracetamolum + Coffeinum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Table of Contents
1. What Gripex Control is and what it is used for
2. Important information before taking Gripex Control
3. How to take Gripex Control
4. Possible side effects
5. How to store Gripex Control
6. Contents of the pack and other information

1. What Gripex Control is and what it is used for

Gripex Control is indicated for the relief of: muscular, joint, and bone pain of various origins, headache, migraine, neuralgia, sore throat, toothache, menstrual pain, post-traumatic and postoperative pain, as well as mild to moderate cancer-related pain. It is also used to reduce fever associated with colds, influenza, and flu-like conditions.

If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before taking Gripex Control

Do not take Gripex Control:

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
• if you have any of the following conditions: congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase, alcoholic liver disease, severe hepatic or renal insufficiency, cardiac arrhythmias;
• during treatment with MAO inhibitors or within 2 weeks after discontinuation of such treatment;
• during treatment with zidovudine;
• in women during the first trimester of pregnancy or during breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before taking Gripex Control, discuss it with your doctor or pharmacist.

• This medicine contains paracetamol. Due to the risk of overdose, check whether other medicines you are taking also contain paracetamol. Do not take other paracetamol-containing medicines simultaneously (e.g. certain analgesics, antipyretics, or medicines used to treat cold and flu symptoms), as this may lead to paracetamol overdose, which can cause life-threatening liver damage.

• Do not exceed the recommended dose. In case of overdose, contact a doctor immediately, even if you feel well (see also section 3, "Taking more than the recommended dose of Gripex Control").

• Use with caution in patients with hepatic impairment, chronic alcohol abuse, or malnutrition, as this increases the risk of liver damage.

• Use with caution in patients with renal impairment, bronchial asthma, hyperthyroidism, or sleep disorders such as insomnia.

• Particular risk of liver damage exists in fasting patients and those who regularly consume alcohol.

During treatment with Gripex Control, inform your doctor immediately if you have severe underlying conditions, including severe renal dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (a disturbance in blood and body fluid balance) have been reported in patients taking paracetamol regularly over a long period or in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, vomiting.

Children
This medicine must not be used in children under 12 years of age.

Gripex Control and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take Gripex Control simultaneously with other medicines containing paracetamol or caffeine.

Before taking Gripex Control, consult your doctor if you are taking any of the following: oral antidiabetic drugs, anticoagulants (e.g. warfarin, coumarins), rifampicin (used in tuberculosis treatment), antiepileptic drugs, sedatives or hypnotics, MAO inhibitors (used, among others, in depression), zidovudine (an antiviral drug used in HIV infection), sympathomimetic drugs (e.g. decongestants, appetite suppressants, amphetamine-like psychostimulants), thyroid hormones, oral contraceptives, cimetidine (used mainly in peptic ulcer disease), chloramphenicol (an antibiotic), quinolones (bactericidal antibiotics), or verapamil (used in heart diseases).

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Taking Gripex Control with food, drink, and alcohol
See section 3.
Do not drink alcohol while taking this medicine, as it increases the risk of liver damage.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use during the first trimester of pregnancy. During the second and third trimesters, consult your doctor before using this medicine.
Do not use during breastfeeding.

Driving and using machines
Gripex Control has no effect on the ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per single dose (2 tablets), i.e. it is considered "sodium-free".

3. How to use Gripex Control

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents over 12 years of age:
Orally, 1 or 2 tablets every 4 to 6 hours (maximum 8 tablets per day).
Use in children
Do not give to children under 12 years of age.
It is recommended to take the medicine on an empty stomach, as this allows for faster analgesic and antipyretic action.
The break line on the tablet is intended only to facilitate crushing the tablet for easier swallowing and does not indicate equal dosing.
Taking more than the recommended dose of Gripex Control
In case of overdose, seek immediate medical advice from a doctor, even if the patient feels well. If less than 1 hour has passed since the overdose, induce vomiting. Immediate contact with a doctor is essential, as specialized hospital treatment may be necessary.
Symptoms may include severe nausea, vomiting, excessive sweating, drowsiness, general weakness, abdominal pain, increased urination, dehydration, and fever. Severe poisoning may manifest as cardiac arrhythmia and tonic-clonic seizures. Some symptoms may resolve the next day, despite the onset of life-threatening liver damage, which subsequently becomes apparent through upper abdominal discomfort, recurrence of nausea, and jaundice.
Missed dose of Gripex Control
Do not take a double dose to make up for a missed dose.
Stopping the use of Gripex Control
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
These include:
If any of the symptoms listed below occur, do not take the medicine and contact a doctor immediately.
These are life-threatening conditions.

• Rarely occurring - skin allergic reactions such as urticaria, rash
• Very rarely occurring - severe skin reactions: rash with blisters all over the body or erosions in the mouth, eyes, genital organs and on the skin, or rupturing giant blisters, peeling of large skin sheets, accompanied by weakness, fever and joint pain

Rarely occurring side effects (may affect less than 1 in 1,000 people):

• agranulocytosis (severe reduction or absence of white blood cells);
• nausea, vomiting, digestive disturbances.

Very rarely occurring side effects (may affect less than 1 in 10,000 people):

• thrombocytopenia (reduced number of blood platelets);
• renal colic, necrosis of renal papillae, acute kidney failure.

Side effects with unknown frequency (cannot be estimated from available data):

• increased heart rate;
• insomnia, difficulty concentrating, irritability, muscle tremors;
• serious condition which may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Gripex Control

Store below 30°C.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the cardboard box
and on the immediate packaging (month/year).
Blister labelling applied: EXP - expiry date, Lot - batch number.

6. Contents of the packaging and other information

What Gripex Control contains
The active substances in this medicine are:
paracetamol 500 mg
caffeine 50 mg.
The other ingredients are: povidone, microcrystalline cellulose, sodium carboxymethyl starch (Type A),
anhydrous colloidal silicon dioxide, magnesium stearate.

What Gripex Control looks like and contents of the pack
White, oblong, biconvex tablets with a score line on both sides.
Packaged in blisters and cardboard boxes containing the leaflet.
Medicine is available in the following pack sizes:
2, 4, 6, 8, 10, 12 tablets per blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław, Poland
For further information regarding this medicine, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw, Poland
tel.: +48 (22) 543 60 00