Losedin

Package leaflet: Information for the patient

Losedin 5 mg tablets, 10 mg tablets

amlodipine
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losedin is and what it is used for

Losedin contains the active substance amlodipine, which belongs to a class of medicines called
"calcium antagonists" and works by lowering blood pressure and reducing the workload of the heart.
Losedin is used:

• for the treatment of high blood pressure (hypertension);
• for the treatment of chest pain known as angina (angina pectoris), including a rare form called Prinzmetal's angina or variant angina.

In patients with high blood pressure, this medicine works by relaxing blood vessels so that blood
can flow more easily. In patients with angina, Losedin improves blood supply to the heart,
increasing oxygen delivery, thereby preventing chest pain. This medicine does not provide
immediate relief of angina-related chest pain.

2. What you should know before taking Losedin

Do not take Losedin:

• if you are allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6) or to any other calcium antagonists;
• if you have severe low blood pressure (severe hypotension);
• if you are in shock, including cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
• if you have narrowing of the aortic heart valve (e.g. severe aortic stenosis);
• if you have inadequate heart function following an acute myocardial infarction;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Losedin if:

• you have recently had a heart attack;
• you have severe high blood pressure (hypertensive crisis);
• you have heart problems (heart failure);
• you have liver problems (hepatic insufficiency);
• you have kidney problems (renal insufficiency);
• you are elderly and your dose needs to be increased (see “Use in the elderly”).

Children and adolescents
Losedin must not be used in children under 6 years of age, as studies have not been conducted to demonstrate the safety and efficacy of the medicine in the pediatric population.

Other medicines and Losedin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No interaction with pharmacological or laboratory tests is known.
The effects of Losedin may be influenced by, or may influence, the following medicines:

• ketoconazole, itraconazole (medicines used to treat fungal infections)
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John's wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (a medicine used by infusion to treat severe disturbances in body temperature)
• simvastatin (a medicine used to lower cholesterol levels)
• tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to modify the way the immune system works) cyclosporine (an immunosuppressant)

The blood pressure-lowering effects of amlodipine are additive to the blood pressure-lowering effects of other antihypertensive medicines.

Losedin with food and drink
People taking Losedin must not drink grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an enhanced hypotensive effect of Losedin.

Losedin contains Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Losedin is contraindicated during pregnancy, as no studies have been conducted to demonstrate its safety. If you are pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor, who will evaluate with you the risks and benefits of treatment with Losedin.

Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, inform your doctor before taking Losedin.

Driving and using machines
Losedin may have mild or moderate effects on the ability to drive or use machinery, especially at the beginning of treatment.
Do not drive or operate machinery if, after taking Losedin, you experience headache, dizziness, nausea, or fatigue.

3. How to take Losedin

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 5 mg of amlodipine once daily. The dose may be
increased to 10 mg of amlodipine once daily.
Use in elderly patients
If you are elderly, your doctor will carefully evaluate any dose increase.
Use in patients with kidney (renal impairment) or liver (hepatic impairment) problems

• if you have liver problems, treatment with amlodipine should be started at the lowest dose, and any dose adjustment should be made gradually;
• if you have kidney problems, you may use Losedin at the usual doses.

Use in children and adolescents
For children and adolescents aged between 6 and 17 years, the recommended starting dose is 2.5
mg of amlodipine once daily. The maximum recommended dose is 5 mg once daily.
The 2.5 mg dose cannot be obtained from Losedin 5 mg tablets, as these tablets cannot
be split into equal parts.
Losedin must not be used in children under 6 years of age.
If you take more Losedin than you should
If you take more Losedin than you should, the following symptoms may occur: a marked
decrease in blood pressure (hypotension), which may lead to shock, or an increased heart
rate (tachycardia).
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which
may develop up to 24–48 hours after ingestion.
In case of accidental overdose, seek immediate medical attention at a doctor's office or the nearest hospital.
If you forget to take Losedin
If you forget to take Losedin, skip the missed dose and take the tablet at your usual time the next day.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Losedin
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Contact your doctor immediately if you experience any of the following side effects after
taking this medicine.
∙ Severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis or other allergic reactions).

Very common side effects

• Edema (manifesting as swelling that may affect various organs (arms, legs, ankles, eye))

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

• Drowsiness, dizziness and headache (especially at the beginning of treatment);
• Palpitations (awareness of your heartbeat), hot flushes;
• Abdominal pain and nausea;
• Feeling of fatigue;
• Changes in bowel habits, diarrhoea, constipation, indigestion;
• Visual disturbances, double vision.

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

• Sleep disorders or mood changes (e.g. anxiety), depression;
• Tremor;
• Changes in taste or smell;
• Tingling sensation and altered sensitivity;
• Loss of consciousness;
• Ringing in the ears (tinnitus);
• Decreased blood pressure;
• Breathing difficulties;
• Irritation or inflammation of the inner lining (mucosa) of the nose (rhinitis);
• Cough;
• Vomiting;
• Dry mouth;
• Digestive disturbances;
• Itchy skin rashes, red patches on the skin, changes in skin colour (purpura, skin discoloration, rash);
• Excessive sweating (hyperhidrosis);
• Hair loss (alopecia);
• Limb pain;
• Muscle and joint pain;
• Muscle cramps;
• Back pain;
• Problems with urination, for example increased need to urinate at night or increased frequency of urination;
• Chest pain;
• Feeling unwell or pain;
• Weight gain or weight loss;
• Inability to achieve an erection, breast discomfort or breast enlargement in men.

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

• Confusion

Very rare side effects (may affect up to 1 in 10,000 people):

• Low levels of certain blood cells (leucopenia, thrombocytopenia);
• Allergic reactions;
• High blood sugar levels (hyperglycaemia);
• A condition called hypertonia which may cause muscle spasms and tremor;
• A nerve disorder called peripheral neuropathy which may cause weakness, tingling or tremor;
• Heart attack and changes in heart rhythm (bradycardia, tachycardia, atrial fibrillation);
• Inflammation of blood vessels (vasculitis);
• Inflammation of the pancreas (pancreatitis);
• Inflammation of the stomach (gastritis);
• Swollen gums;
• Inflammation of the liver (hepatitis);
• Yellowing of the skin (jaundice);
• Increase in certain liver substances (liver enzymes);
• Swelling of the legs, arms, face, mucous membranes or tongue (angioedema);
• Skin rashes characterized by redness, skin spots, swelling, peeling of the skin and itching (erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke's edema);
• Light sensitivity.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losedin

Store the medicine at a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Losedin contains
Losedin 5 mg tablets:

• The active substance is: amlodipine besylate. One tablet contains 6.94 mg of amlodipine besylate (equivalent to 5 mg of amlodipine base).
• The other components are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate.

Losedin 10 mg tablets:

• The active substance is: amlodipine besylate. One tablet contains 13.87 mg of amlodipine besylate (equivalent to 10 mg of amlodipine base).
• The other components are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate.

Description of the appearance of Losedin and contents of the pack
Losedin 5 mg tablets: pack containing 28 tablets of 5 mg
Losedin 10 mg tablets: pack containing 14 tablets of 10 mg

Marketing Authorization Holder:
Eberlife Farmaceutici S.p.A.
Via G. Porzio SNC – 80143 Napoli (Na) - CDN Isola E1

Manufacturer:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR)
September 2022