Gripex Control

Package Leaflet: Information for the Patient

Gripex Control,500 mg + 50 mg, tablets
Paracetamol + Caffeine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

The indications for use of this medicine are: muscle, joint, and bone pain of various origins, headaches, migraines, neuralgia, sore throat, toothache, and menstrual pain, post-traumatic, post-operative, and tumor pain of mild or moderate intensity, feverish conditions resulting from colds, flu, and flu-like conditions.
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Gripex Control

When not to take Gripex Control:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have the following diseases: congenital glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency, alcoholism, severe liver or kidney failure, heart rhythm disorders;
• during treatment with MAO inhibitors and for 2 weeks after stopping these medications;
• during treatment with zidovudine;
• it should not be taken by women in the first trimester of pregnancy and during breastfeeding;
• it should not be taken by children under 12 years of age.

Warnings and precautions

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

• The medicine contains paracetamol. Due to the risk of overdose, check if other medications you are taking do not contain paracetamol. Do not take other medications containing paracetamol (including some painkillers, antipyretics,

used to treat cold and flu symptoms) due to the risk of overdose, which can lead to life-threatening liver damage.

• Do not take a higher dose than recommended. In case of overdose, contact your doctor immediately, even if you feel well (see also section 3 "Taking a higher dose of Gripex Control than recommended").
• Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals poses a risk of liver damage.
• Use with caution in people with kidney failure, asthma, hyperthyroidism, sleep disorders in the form of insomnia.
• There is a special risk of liver damage in fasting individuals and regular alcohol drinkers.

While taking Gripex Control, immediately inform your doctor if you have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (abnormality of blood and body fluids), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.

Children

The medicine should not be taken by children under 12 years of age.

Gripex Control and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Gripex Control with other medicines containing paracetamol and caffeine.
In case of concurrent use of oral antidiabetic drugs, anticoagulants (warfarin, coumarin), rifampicin (a drug used to treat tuberculosis), antiepileptic drugs, sedatives and hypnotics, MAO inhibitors (drugs used, among others, in depression), zidovudine (an antiviral drug used in HIV infection), sympathomimetic drugs (i.e., decongestants, appetite suppressants, and psychostimulants similar to amphetamine), thyroid hormones, oral contraceptives, cimetidine (a drug used mainly in gastric and duodenal ulcer disease), chloramphenicol (an antibiotic), quinolones (bactericidal drugs), and verapamil (a drug used in heart disease) - consult your doctor before taking Gripex Control.
Tell your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Taking Gripex Control with food, drink, and alcohol

See section 3.
Do not drink alcohol while taking the medicine, due to the increased risk of liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take in the first trimester of pregnancy. In the second and third trimesters, consult your doctor before taking the medicine.
Do not take during breastfeeding.

Driving and using machines

It does not affect the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodium per single dose (2 tablets), which means the medicine is considered "sodium-free".

3. How to take Gripex Control

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult your 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 pain-relieving and antipyretic effects.
The dividing line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.

Taking a higher dose of Gripex Control than recommended

If you have taken a higher dose of the medicine than recommended, contact your doctor immediately, even if you feel well. If the overdose occurred no more than 1 hour ago, induce vomiting. Contact your doctor immediately, as specialized treatment in a hospital setting may be necessary.
Symptoms may include: severe nausea, vomiting, excessive sweating, drowsiness, general weakness, abdominal pain, increased urination, dehydration, and fever. More severe poisoning is characterized by cardiac arrhythmia and tonic-clonic seizures. Some symptoms may resolve the next day, despite the fact that life-threatening liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice.

Missing a dose of Gripex Control

Do not take a double dose to make up for a missed dose.

Stopping treatment with Gripex Control

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
They include:

If you experience any of the following symptoms, do not take the medicine and contact your doctor immediately. These are life-threatening conditions.

• Rare - allergic skin reactions, such as hives, rash
• Very rare - severe skin reactions: rash with blisters all over the body or ulcers in the mouth, eyes, genitals, and skin, or bursting large blisters, peeling off large patches of skin, accompanied by weakness, fever, and joint pain

Uncommon side effects (may affect up to 1 in 100 people):

• agranulocytosis (a significant decrease in the number of white blood cells or their absence);
• nausea, vomiting, digestive disorders.

Rare side effects (may affect up to 1 in 1,000 people):

• thrombocytopenia (decreased platelet count);
• renal colic, renal papillary necrosis, acute kidney failure.

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

• increased heart rate;
• insomnia, inability to concentrate, irritability, muscle tremors;
• a serious condition that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gripex Control

Store in a temperature below 30°C.
Keep the medicine out of sight and reach of children.
Do not take the medicine after the expiration date stated on the carton and blister pack (month/year).
The applied labeling for the blister is: EXP - expiration date, Lot - batch number.

6. Contents of the pack and other information

What Gripex Control contains

The active substances of the medicine are:
paracetamol
500 mg
caffeine
50 mg.
The other ingredients are: povidone, microcrystalline cellulose, sodium carboxymethylcellulose (Type A),
silica colloidal anhydrous, magnesium stearate.

What Gripex Control looks like and what the pack contains

White, elongated tablets, convex on both sides, with a dividing line.
Packaged in blisters and a carton with a leaflet.
The medicine is available in packs of:
2, 4, 6, 8, 10, 12 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
To obtain more detailed information about this medicine, contact:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00

Date of last revision of the leaflet: