Label: information for the user

Normostat 120 mg hard capsules

Orlistat

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Normostat and what it is used for

2. What you need to know before starting to take Normostat

3. How to take Normostat

4. Possible adverse effects

5. Storage of Normostat

6. Contents of the pack and additional information

Normostat is a medication used to treat obesity. It acts on your digestive system by preventing the digestion of approximately one-third of the fat contained in the food you consume. Normostat binds to enzymes in your digestive system (lipases) preventing them from hydrolyzing part of the fat you have ingested during a meal. 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.

Do not take Normostat

• If you are allergic (hypersensitive) to orlistat or to any of the other components 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 breastfeeding.

Warnings and precautions

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

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

This medication may cause a non-harmful change in your bowel habits, such as the presence of greasy or oily stools, due to the elimination of undigested fat through the stool. The likelihood of this occurring may increase if Normostat is taken with a diet rich in fat. Additionally, your daily intake of fat should be distributed evenly among the three main meals, as taking Normostat with a meal high in fat may increase the likelihood of gastrointestinal side 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 medications

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

This is important as using more than one medication at the same time may increase or decrease its effect.

Normostat may modify the action of:

• Anticoagulants (e.g. warfarin), so your doctor may need to monitor your blood coagulation.
• Ciclosporin. Do not administer concurrently with ciclosporin. Your doctor may need to monitor your ciclosporin plasma levels more frequently than usual.
• Sodium iodide and/or levothyroxine. They may cause cases of hypothyroidism and/or alterations in thyroid control.
• Amiodarone. Consult your doctor.
• Medications for HIV/AIDS.
• Medications for depression, psychiatric disorders, or anxiety.

Normostat reduces the absorption of some fat-soluble supplements, 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 reducing the absorption of antiepileptic medications, which may lead to the appearance of seizures. Consult your doctor if you consider that the frequency or severity of seizures has changed while taking Normostat with antiepileptic medications.

Normostat is not recommended for those taking acarbose (anti-diabetic medication 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 a meal. Swallow the capsule with water.

Pregnancy and breastfeeding

Normostat is not recommended during pregnancy.

Do not breastfeed your child during treatment with Normostat, as it is unknown whether Normostat passes into breast milk.

Driving and operating machinery

Normostat has no known effect on the ability to drive or operate machinery.

Normostat contains sodium

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

Follow exactly the administration instructions for Normostat as indicated by your doctor. In case of 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 the meal. The capsule should be taken with water.

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

Normostat only acts in the presence of dietary fats. Therefore, you do not need to take Normostat if you do not take a main meal or if you take 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 medication was not effective or well tolerated and may change your treatment unnecessarily.

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

Normostat has been studied in clinical trials of up to 4 years' duration.

If You Take More Normostat Than You Should

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

If You Forget to Take Normostat

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

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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

The majority of unwanted effects related to the use of Normostat are the result of its local action on the digestive system. These symptoms are generally moderate, occur at the beginning of treatment, and are mainly present after meals with high levels of fat.

Normally, these symptoms disappear if you continue with the 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 greasy stools, liquid stools, more frequent bowel movements, flu, low blood sugar (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, fecal incontinence, swelling (experienced by some patients with type 2 diabetes), alterations in teeth and gums, irregular menstrual cycle, fatigue, anxiety.

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

Allergic reactions. The main symptoms are: itching, skin rash, hives (areas of skin that are slightly elevated, itchy, and 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). Symptoms may include yellowing of the skin and eyes, itching, dark-colored urine, stomach pain, and liver tenderness (indicated by pain under the front part of the thoracic 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 may cause kidney stones). See Section 2: Warnings and precautions. Interactions with anticoagulants.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light and humidity.

Do not dispose of medications through drains or trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Normostat

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

The other components are:

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

Appearance of the product and content of the packaging

Normostat capsules have a light blue body and cap.

Normostat is available in blister packs of 42 and 84 capsules. Some package sizes may only be marketed.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing:

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

Last review date of this leaflet: May 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/