Package leaflet: Information for the patient

Zyfoqam, 5 mg, coated tablets
Linagliptinum
Please read the following information carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Zyfoqam is and what it is used for
Important information before taking Zyfoqam
How to take Zyfoqam
Possible side effects
How to store Zyfoqam
Contents of the pack and other information

1. What Zyfoqam is and what it is used for

Zyfoqam contains the active substance linagliptin, which belongs to a group of medicines called
"oral antidiabetic medicines". Oral antidiabetic medicines are used in the treatment of high blood sugar levels. These medicines help the body reduce the amount of sugar in the blood.
Zyfoqam is used in the treatment of type 2 diabetes in adults when the disease cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulfonylurea derivatives) or with diet and exercise alone. Zyfoqam may be used together with other antidiabetic medicines, such as metformin, sulfonylurea derivatives (e.g. glimepiride, glipizide), empagliflozin, or insulin.
It is important to continue the diet and exercise regimen recommended by your doctor or nurse.

2. Important information before taking Zyfoqam

When not to take Zyfoqam

if the patient is allergic to linagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Zyfoqam, discuss this with your doctor, pharmacist, or
nurse:

if the patient has type 1 diabetes (the patient's body does not produce insulin) or diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting). Zyfoqam should not be used to treat these conditions.
if the patient is taking an antidiabetic medicine called a sulfonylurea (e.g. glimepiride, glipizide), the doctor may recommend reducing the dose of the sulfonylurea when Zyfoqam is taken concomitantly, to avoid excessively low blood sugar levels.
if the patient has had an allergic reaction to any other medicines previously taken to lower blood sugar levels.
if the patient has or has had a history of pancreatic disease.

If the patient experiences symptoms of acute pancreatitis, such as severe and persistent abdominal pain,
contact a doctor.
If the patient develops blisters on the skin, this may be a sign of a condition called bullous pemphigoid.
The doctor may advise the patient to stop taking Zyfoqam.
Diabetic skin changes are common complications of diabetes. Follow the skin and foot care advice
provided by the doctor or nurse.

Children and adolescents
Zyfoqam must 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 unknown whether 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 medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
In particular, tell the doctor if the patient is taking medicines containing any of the following active substances:

carbamazepine, phenobarbital, or phenytoin. These medicines may be used to treat seizures (epilepsy) or chronic pain.
rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
It is unknown whether Zyfoqam is harmful to unborn children; therefore, use of Zyfoqam during
pregnancy is not recommended.
It is unknown whether Zyfoqam passes into human milk. The doctor must decide whether to discontinue
breastfeeding or to discontinue/withhold treatment with Zyfoqam.

Driving and operating machinery
Zyfoqam has no effect or a negligible effect on the ability to drive and operate machinery.
However, taking Zyfoqam in combination with sulfonylurea medicines and/or insulin may cause
low blood sugar (hypoglycaemia), which may affect the ability to drive and operate machinery or
work without secure footing.
Nevertheless, more frequent monitoring of blood glucose levels is recommended to minimize the risk
of hypoglycaemia, especially when Zyfoqam is used in combination with sulfonylureas and/or insulin.

3. How to take Zyfoqam

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose of Zyfoqam is one 5 mg tablet once daily.
Zyfoqam may be taken with or without food.
Your doctor may recommend taking Zyfoqam together with another oral antidiabetic medicine.
All medicines should be taken as directed by your doctor to achieve the best possible treatment outcome.
Taking more Zyfoqam than recommended
If you take more Zyfoqam than prescribed, you should contact your doctor immediately.
Missing a dose of Zyfoqam

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

Stopping Zyfoqam treatment
Do not stop taking Zyfoqam without first consulting your doctor. Stopping Zyfoqam may lead to increased blood sugar levels.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some symptoms require immediate medical attention.
You should stop taking Zyfoqam and contact your doctor immediately if you experience any of the following symptoms related to low blood sugar levels:
tremor, sweating, anxiety, blurred vision, tingling of the lips, pallor, mood changes or confusion (hypoglycaemia). Hypoglycaemia (frequency: very common, occurs in more than 1 in 10 people) is a known adverse effect of treatment with Zyfoqam when taken concomitantly with metformin and a sulfonylurea derivative.
Allergic reactions (hypersensitivity; frequency: not common, occurs in up to 1 in 100 people) have occurred in some patients during treatment with Zyfoqam, either as monotherapy or in combination with other antidiabetic medicines, which may be severe, including wheezing and difficulty breathing (bronchospasm; frequency: not known, frequency cannot be estimated from available data). Some patients experienced rash (frequency: not common), urticaria (urticaria; frequency: rare, occurs in up to 1 in 1,000 people), and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing (angioedema; frequency: rare). If any of the above symptoms occur, you should stop taking Zyfoqam and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and switch you to another antidiabetic medicine.
Pancreatitis (pancreatitis; frequency: rare, occurs in up to 1 in 1,000 people) has occurred in some patients during treatment with Zyfoqam, either as monotherapy or in combination with other antidiabetic medicines.
You should STOP taking Zyfoqam and contact your doctor immediately if you experience any of the following serious adverse reactions:

Severe 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.

During treatment with Zyfoqam, either as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have been reported in some patients:

Common: increased lipase activity in blood.
Not common: inflammation of the nose or throat (pharyngitis), cough, constipation (in combination with insulin), increased amylase activity in blood.
Rare: formation of blisters on the skin (bullous pemphigoid).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the blister and the outer carton box following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use Zyfoqam if the packaging is damaged or there are signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zyfoqam contains

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

What Zyfoqam looks like and contents of the pack
Zyfoqam tablets are red, round, biconvex coated tablets with a diameter of 8.1 mm, embossed with the number "5" on one side and smooth on the other.
The medicine is available in blister packs made of oPA/aluminium/PVC//aluminium foil in cardboard boxes containing 10, 28, 30, or 90 coated tablets, as well as in perforated blister strips made of oPA/aluminium/PVC//aluminium foil, divided into single doses, in cardboard boxes containing 10 x 1, 28 x 1, 30 x 1, or 90 x 1 coated tablet.
Not all pack sizes may be marketed.

Marketing Authorisation 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