NORMOSTAT 120 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Normostat 120 mg Hard Capsules

Orlistat

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.

Contents of the pack

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

1. What Normostat is and what it is used for

Normostat is a medicine used to treat obesity. It works on your digestive system to prevent the digestion of about one-third of the fat contained in the food you eat. Normostat binds to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fats you have eaten during meals. The undigested fat cannot be absorbed and your body eliminates it.

Normostat is indicated for the treatment of obesity, in conjunction with a low-calorie diet.

2. What you need to know before you take Normostat

Do not take Normostat

• If you are allergic (hypersensitive) to orlistat or any of the other ingredients of Normostat.
• If you have chronic malabsorption syndrome (insufficient absorption of nutrients through the digestive tract).
• If you have cholestasis (liver disorder).
• If you are breast-feeding

Warnings and precautions

Weight loss may also affect the dose of medicines you take for other conditions (e.g. high cholesterol or diabetes). Make sure to inform your doctor if you are taking these or other medicines. Weight loss may mean that you need a dose adjustment of these medicines.

To get the maximum benefit from Normostat, you should follow the nutrition program recommended by your doctor. As with any other weight control program, excessive consumption of fat and calories can reduce the effect on weight loss.

This medicine may cause a harmless change in your bowel habits, such as the presence of oily or fatty stools, due to the elimination of undigested fat through the stool. The possibility of this occurring may increase if Normostat is taken with a high-fat diet. Additionally, your daily fat intake should be evenly distributed between the three main meals, as if Normostat is taken with a very high-fat meal, it may increase the possibility of gastrointestinal effects.

In case of severe diarrhea, there may be a failure of oral contraceptives, so it is recommended to use an additional contraceptive method.

In patients with chronic kidney disease, the use of orlistat may be associated with kidney stones. Inform your doctor if you have kidney problems.

Children

Normostat is not indicated for use in children.

Taking Normostat with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or may need to take any other medicines.

This is important because using more than one medicine at the same time can increase or decrease its effect.

Normostat may alter the action of:

• Anticoagulants (e.g. warfarin), so your doctor may need to monitor your blood coagulation.
• Ciclosporin. Concomitant administration with ciclosporin is not recommended. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.
• Iodine salts and/or levothyroxine. They may produce cases of hypothyroidism and/or alterations in the control of hypothyroidism.
• Amiodarone. Consult your doctor.
• Medicines for the treatment of AIDS.
• Medicines for depression, psychiatric disorders, or anxiety.

Normostat reduces the absorption of supplements of some fat-soluble nutrients, especially beta-carotene and vitamin E. Therefore, you should follow your doctor's advice and take a balanced diet rich in fruits and vegetables. Your doctor may recommend a multivitamin supplement.

Orlistat may alter anticonvulsant treatment by decreasing the absorption of antiepileptic medicines, which can lead to the appearance of seizures. Consult your doctor if you think the frequency or severity of seizures has changed when taking Normostat with antiepileptic medicines.

Normostat is not recommended for those taking acarbose (an anti-diabetic drug used for type 2 diabetes).

Taking Normostat with food, drink, and alcohol

Normostat can be taken immediately before, during, or up to one hour after meals. The capsule should be swallowed with water.

Pregnancy and breast-feeding

Normostat is not recommended during pregnancy.

You should not breast-feed your child during treatment with Normostat, as it is not known whether Normostat passes into breast milk.

Driving and using machines

Normostat has no known effect on the ability to drive or use machines.

Normostat contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Normostat

Follow your doctor's instructions for taking Normostat exactly. If you are in doubt, consult your doctor or pharmacist.

The recommended dose of Normostat is one 120 mg capsule taken with each of the three main meals of the day. It can be taken immediately before, during, or up to one hour after meals. The capsule should be taken with water.

Normostat should be taken with a calorie-controlled diet, well-balanced, rich in fruits and vegetables, and containing an average of 30% of calories from fat. Your daily intake of fats, carbohydrates, and proteins should be distributed in three meals. This means you will usually take one capsule at breakfast, one at lunch, and one at dinner. To achieve optimal benefits, avoid eating fatty foods between meals, such as cookies, chocolate, or salty snacks.

Normostat only works in the presence of dietary fat. Therefore, you do not need to take Normostat if you do not eat a main meal or if you eat a meal that does not contain fat.

If for any reason you have not taken your medicine exactly as prescribed, tell your doctor. Otherwise, your doctor may think that this medicine was not effective or well-tolerated and may change your treatment unnecessarily.

Your doctor will stop treatment with Normostat if after 12 weeks you have not lost at least 5% of your initial weight.

Normostat has been studied in clinical trials for up to 4 years.

If you take more Normostat than you should

If you take more capsules than your doctor has prescribed, or if someone else accidentally takes your medicine, contact your doctor, pharmacist, or hospital as you may need medical attention.

If you forget to take Normostat

If you forget to take your medicine at any time, take it as soon as you remember, provided it is within one hour of eating and then continue taking it at the usual intervals. Do not take a double dose to make up for forgotten doses. If you have missed several doses, please inform your doctor and follow the advice given.

Do not change the prescribed dose yourself unless your doctor tells you to.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

If you do not feel well while taking Normostat, tell your doctor or pharmacist as soon as possible.

Most of the unwanted effects related to the use of Normostat are the result of its local action on the digestive system. These symptoms are generally mild, occur at the start of treatment, and are most likely to occur after meals with high levels of fat.

Normally, these symptoms disappear if you continue with treatment and follow the recommended diet.

Very common side effects (affect more than 1 in 10 patients)

Headache, upper respiratory tract infection, abdominal pain or discomfort, urgency or increased need to defecate, flatulence (gas), flatulence (gas) with fecal incontinence, oily or fatty stools, liquid stools, more frequent bowel movements, flu, low blood sugar levels (experienced by some patients with type 2 diabetes)

Common side effects (affect between 1 and 10 in 100 patients)

Lower respiratory tract infection, rectal pain or discomfort, soft stools, incontinence (fecal), swelling (experienced by some patients with type 2 diabetes), changes in teeth and gums, irregular menstrual cycle, fatigue, anxiety.

The following side effects have also been reported, but their frequency cannot be estimated from the available data:

Allergic reactions. The main symptoms are: itching, rash, hives (areas of skin that are slightly raised, that itch and that are paler or redder than the surrounding skin), severe difficulty breathing, nausea, vomiting, and discomfort. Blisters on the skin (including blisters that burst). Diverticulitis. Rectal bleeding. Increases in liver enzyme levels may be detected in blood tests. Hepatitis (inflammation of the liver). The symptoms may include yellowing of the skin and eyes, itching, dark urine, stomach pain, and liver sensitivity (indicated by pain below the front of the rib cage on the right side), sometimes with loss of appetite. Stop taking Normostat if these symptoms appear and inform your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (developed by calcium oxalate that can cause kidney stones). See Section 2: Warnings and precautions. Interactions with anticoagulants.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Normostat

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging to protect from light and moisture.

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

Composition of Normostat

The active substance is orlistat. Each capsule contains 120 mg of orlistat.

The other ingredients are:

• capsule filling: microcrystalline cellulose PH112, sodium carboxymethyl starch (potato) (type A), anhydrous colloidal silica, sodium lauryl sulfate
• capsule body: gelatin, titanium dioxide (E171), indigo carmine (E132).

Appearance of the product and pack contents

Normostat capsules have a light blue body and cap.

Normostat is available in blister packs of 42 and 84 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

Pharmaceutical Works POLPHARMA S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

or

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. BOX 3012 Larisa Industrial Area,

Larisa, 41004

Greece

Date of last revision of this leaflet: May 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/