Libertek - patient leaflet, side effects, dosage

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Takeda GmbH

Production Site Oranienburg

Lehnitzstrasse 70–98

D-16515 Oranienburg

Germany

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

• Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

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• Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted

• At the request of the European Medicines Agency.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

• Additional risk minimisation measures

The Marketing Authorisation Holder shall agree the content and format of the updated educational material with the national competent authority.

The Marketing Authorisation Holder (MAH) should ensure that all Healthcare Professionals who are expected to prescribe Libertek are provided with an updated Educational pack.

The educational pack should contain the following:

• Summary of Product Characteristics and Patient Information Leaflet for Libertek
• Educational material for the physician.
• Copies of the patient card to be given to patients or caregivers before they receive Libertek

The educational material for the prescriber should include information on the following key elements:

> The specific indication approved.

> The fact that Libertek is not indicated for the treatment of COPD patients outside of the approved indication, nor for use in patients with asthma or alpha-1 antitrypsin deficiency.

o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).

• > The potential risk of infections: Libertek should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases. The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.

• > The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g..multiple sclerosis, lupus erythematosus, multifocal leukoencephalo­pathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Libertek should not be initiated or should be stopped in these patients.

• > The potential cardiac risk: Libertek has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.

• > The limited or missing information in patients with liver impairment. Libertek is contraindicated in patients with moderate or severe liver impairment (Child-Pugh B or C). Clinical data are considered insufficient to recommend dose adjustment and caution should be observed in patients with mild liver impairment (Child-Pugh A).

• > The lack of clinical data to support the combination with theophylline and that such combination is not recommended.

Patient Card

The patient card should contain the following key elements:

That they should tell their doctor if they have a history of any of the following con

cancer

insomnia, anxiety, depression, suicidal ideation or behaviour

multiple sclerosis or SLE

infection with tuberculosis, herpes, hepatitis, HIV

That patients or their caregivers should tell their doctor if the

insomnia, anxiety, depression, changes in behaviour or severe infection

That patients should tell their doctor if they are taking

That Libertek may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.

The patient card should include an area where patients can record their weight and the date they weighed themselves and they should be asked to bring the patient card with them at each visit.

The MAH shall complete, within the stated timeframe, the below measures:

Description kJ?)

Due date

ANX 2.1 – The MAH commits to conduct a long-term comparative observational safety study. This study should be appropriate to compare the incidences of all-cause mortality, major cardiovascular events, new diagnosis of cancer, all-cause hospitalisation, hospitalisation related to respiratory disease, suicide or hospitalisation for suicide attempt, and new diagnosis of depression, tuberculosis or viral hepatitis B or C in roflumilast treated COPD patients compared with COPD patients not treated with roflumilast.

Interim Study Reports – with each PSUR Final study report by 31/03/2021

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Libertek 500 micrograms film-coated tablets roflumilast

2. STATEMENT OF ACTIVE SUBSTANCE(S)

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

• 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

SE-151 85 Södertälje

Sweden

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

• 1. NAME OF THE MEDICINAL PRODUCT

Libertek 500 micrograms tablets roflumilast

• 2. NAME OF THE MARKETING AUTHORISATION HOLDER

AstraZeneca AB

Package leaflet: Information for the patient

Libertek 500 micrograms film-coated tablets

Roflumilast

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet :

• 1. What Libertek is and what it is used for

• 2. What you need to know before you take Libertek

• 3. How to take Libertek

• 4. Possible side effects

• 5. How to store Libertek

• 6. Contents of the pack and other information

1 What Libertek is and what it is used for

Libertek contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase-4 inhibitor. Roflumilast reduces the activity of phosphodiesterase-4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD). Thus Libertek eases breathing problems.

Libertek is used for maintenance treatment of severe COPD in adults who in the past had frequent worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis. COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation). This leads to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing. Libertek is to be used in addition to bronchodilators.

2 What you need to know before you take Libertek

Do not take Libertek

• – if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section

• 6)

• – if you have moderate or severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Libertek

Sudden attack of breathlessness

Libertek is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack. Libertek will not help you in this situation.

Body weight

You should check your body weight on a regular basis. Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).

Other diseases

Libertek is not recommended if you have one or more of the following diseases:

• – severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalo­pathy (PML)

• – severe acute infectious diseases such as tuberculosis, or acute hepatitis

• – cancer (except basal-cell carcinoma, a slow-growing type of skin cancer)

• – or severe impairment of the heart function

There is a lack of relevant experience with Libertek under these conditions. You should talk to your

doctor, if you are diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster. Please talk to your doctor if you have one of these diseases.

• Symptoms you should be aware of /v«'

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of treatment with Libertek. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

Libertek is not recommended in patients wit behaviour. You may also experience sleeple starting treatment with Libertek, inform you

and of any additional medicines you side effects. You or your caregiver s behaviour or mood and of any suicid

Children and adolescents

Libertek should not be used by children and adolescents under 18 years of age.

Other medicines and Libertek

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following:

• – a medicine containing theophylline (a medicine to treat respiratory diseases), or

• – a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.

• – a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin (a medicine to treat bacterial infections) or cimetidine (a medicine to treat stomach ulcers or heartburn).

The effect of Libertek may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). Ask your doctor for advice.

Libertek may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their dose unless advised by your doctor.

Pregnancy and breast-feeding

Do not take Libertek if you are or plan to become pregnant, think you may be pregnant, or are breast-feeding. You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Libertek may be harmful for the unborn baby.

Driving and using machines

Libertek has no influence on the ability to drive and use machines.

Libertek contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 How to take Libertek

Always take this medicine exactly as your doctor has told you. Check with your do you are not sure.

The recommended dose is one 500 micrograms tablet once daily.

Swallow the tablet with some water. You may take this medicine wi at the same time every day.

You may need to take Libertek for several weeks to achieve its beneficial effect.

nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure. Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.

If you forget to take Libertek

If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day.

If on one day you have forgotten to take a tablet of Libertek, just carry on the next day with the next tablet as usual. Continue taking your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Libertek

It is important to continue taking Libertek for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You may experience diarrhoea, nausea, stomach ache or headache during the first weeks of treatment with Libertek. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

Some side effects could be serious. In clinical studies and post-marketing experience, rare instances of suicidal thinking and behaviour (including suicide) were reported. Please notify your doctor immediately of any suicidal thoughts you may have. You may also experience sleeplessness (common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).

In uncommon cases allergic reactions may occur. Allergic reactions may affect the skin and in rare cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat. In case of an allergic reaction, stop taking Libertek and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take all your medicines and this leaflet with you and provide full information of your current medications.

Other side effects include the following:

Common side effects (may affect up to 1 in 10 people)

• – diarrhoea, nausea, stomach ache

• – weight decrease, decreased appetite

• – headache

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

• – trembling, sensation of spinning head (vertigo), dizziness

• – sensation of rapid or irregular heartbeat (palpitations)

• – gastritis, vomiting

• – reflux of stomach acid to the gullet (acid regurgitations), indigestion

• – rash

• – muscle pain, muscle weakness or cramps

• – back pain

• – feeling of weakness or tiredness, feeling unwell.

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

• – male breast enlargement

• – decreased sense of taste

• – respiratory tract infections (excluding pneumonia)

• – bloody stools, constipation

• – elevation of liver or muscle enzymes (seen in blood tests)

• – wheals (urticaria).

* //2r

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Libertek

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Libertek contains

• – The active substance is roflumilast. Each film-coated tablet (tablet) contains 500 micrograms

roflumilast.

• – The other ingredients are:

• – Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate,

• – Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).

What Libertek looks like and contents of the pack

Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with ‚D‘ on one side.

Each pack contains 10, 30, or 90 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70–98

16515 Oranienburg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Detailed information on this medicine is available on the European Medicines Agency web site:

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