ZYFOQAM 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Zyfoqam, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
3. What is Zyfoqam and what is it used for
4. Important information before you take Zyfoqam
   1. When not to take Zyfoqam
   2. Warnings and precautions
   3. Children and adolescents
   4. Zyfoqam with other medicines
   5. Pregnancy and breast-feeding
   6. Driving and using machines
5. How to take Zyfoqam
   1. If you take more Zyfoqam than you should
   2. If you forget to take Zyfoqam
   3. If you stop taking Zyfoqam
6. Possible side effects
   1. Reporting of side effects
7. How to store Zyfoqam
8. Contents of the pack and other information
   1. What Zyfoqam contains
   2. What Zyfoqam looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

Zyfoqam, 5 mg, Film-Coated Tablets

Linagliptin

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Zyfoqam and what is it used for

Zyfoqam contains the active substance linagliptin, which belongs to a group of medicines called "oral anti-diabetic medicines". Oral anti-diabetic medicines are used to treat high blood sugar levels. These medicines help the body to reduce the amount of sugar in the blood.
Zyfoqam is used to treat type 2 diabetes in adults when the disease cannot be controlled by diet and exercise or by diet and exercise and another oral anti-diabetic medicine (metformin or sulphonylurea). Zyfoqam can be used in combination with other anti-diabetic medicines, such as metformin, sulphonylurea (e.g., glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue to follow the diet and exercise plan as recommended by your doctor or nurse.

2. Important information before you take Zyfoqam

When not to take Zyfoqam

• if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Zyfoqam, talk to your doctor, pharmacist, or nurse:

• if you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Zyfoqam should not be used to treat these conditions.
• if you are taking a sulphonylurea (e.g., glimepiride, glipizide), your doctor may advise you to reduce the dose of the sulphonylurea when taking Zyfoqam to avoid too low blood sugar levels.
• if you have had an allergic reaction to any other medicines used to reduce blood sugar levels.
• if you have or have had pancreatitis (inflammation of the pancreas).

If you experience symptoms of acute pancreatitis, such as severe and persistent abdominal pain, you should contact your doctor.
If you develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Zyfoqam.
Diabetic skin changes are common complications of diabetes. You should follow the recommendations for skin and foot care given by your doctor or nurse.

Children and adolescents

Zyfoqam should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Zyfoqam with other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking medicines that contain any of the following active substances:

• carbamazepine, phenobarbital, or phenytoin. These medicines are used to treat epilepsy or chronic pain.
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if Zyfoqam is harmful to the unborn child. Therefore, it is recommended to avoid taking Zyfoqam during pregnancy.
It is not known if Zyfoqam passes into breast milk. Your doctor will decide whether you should stop breast-feeding or stop/wirthhold Zyfoqam treatment.

Driving and using machines

Zyfoqam has no or negligible influence on the ability to drive and use machines.
Taking Zyfoqam in combination with sulphonylurea and/or insulin may cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without strong support for your legs.
However, it is recommended to check your blood glucose levels more frequently to minimize the risk of hypoglycaemia, especially when taking Zyfoqam in combination with sulphonylurea and/or insulin.

3. How to take Zyfoqam

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Zyfoqam is one 5 mg tablet once a day.
Zyfoqam can be taken with or without food.
Your doctor may advise you to take Zyfoqam in combination with another oral anti-diabetic medicine. All medicines should be taken as directed by your doctor to get the best results.

If you take more Zyfoqam than you should

If you take more Zyfoqam than you should, contact your doctor immediately.

If you forget to take Zyfoqam

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.
• Do not take a double dose to make up for a forgotten dose. Never take two doses on the same day.

If you stop taking Zyfoqam

Do not stop taking Zyfoqam without first talking to your doctor. If you stop taking Zyfoqam, your blood sugar levels may increase.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention.
Stop taking Zyfoqam and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar levels:
shaking, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes, or confusion (hypoglycaemia). Hypoglycaemia (frequency: may occur very often, occurs in more than 1 in 10 people) is a known side effect of treatment with Zyfoqam when taken in combination with metformin and sulphonylurea.

• Serious and persistent abdominal pain (in the stomach area), which may radiate to the back, as well as nausea and vomiting, as these may be symptoms of pancreatitis.

When taking Zyfoqam alone or in combination with other diabetes medicines, some patients have experienced the following side effects:

• Common: increased activity of lipase in the blood.
• Uncommon: inflammation of the nose or throat (nasopharyngitis), cough, constipation (when taken with insulin), increased activity of amylase in the blood.
• Rare: blistering of the skin (bullous pemphigoid).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zyfoqam

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Do not use Zyfoqam if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zyfoqam contains

• The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
• The other ingredients are: Tablet core: mannitol (E421), corn starch, maize starch, povidone (E1201), magnesium stearate (E470b) Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172)

What Zyfoqam looks like and contents of the pack

Zyfoqam tablets are red, round, biconvex film-coated tablets with a diameter of 8.1 mm, with "5" engraved on one side and smooth on the other side.
The medicine is available in blisters of oPA/aluminium/PVC//aluminium in cartons containing 10, 28, 30, 90 film-coated tablets, and in perforated unit dose blisters of oPA/aluminium/PVC//aluminium in cartons containing 10 x 1, 28 x 1, 30 x 1, 90 x 1 film-coated tablet.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
tel.: +48 17 865 51 00

Manufacturer

Genepharm S.A.
18th Km Marathonos Avenue
153 51 Pallini
Greece

Date of last revision of the package leaflet: