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Where can I report any side effects after taking a Focus Care medicine?

Medicines can cause side effects. Although many side effects are identified in clinical trials, rare side effects may sometimes come to light only after the medicine has been used on a larger scale.

It is therefore crucial that you report any suspected side effects, even if you are unsure of their cause. These reports allow us to better understand the nature and frequency of side effects and take action if necessary.

Your report helps to guarantee the safety of our medicines and protect patients’ health.

You can report side effects by:

e-mailing pv@focuscare.nl
calling +31 (0)85 – 792 08 00 or
completing the form below

This information will be used solely to register the side effects. Your privacy will be guaranteed at all times.

Which medicine is causing the side effect?(Required)

You can mention the name of other medicines you are taking or using later in the form.

RVG-number

LOT-number

Note: Lot numbers are also known as ‘batch numbers’. This number is shown on the packaging of the medicine.

Expiry date

DD slash MM slash YYYY

Note: This number is shown on the packaging of the medicine.

What is the daily dose of our product?

For example, this could be one tablet taken once a day.

When did you start taking or using our product?(Required)

DD slash MM slash YYYY

Note: If you do not know the precise date, please provide an accurate guess.

Are you still taking or using our product?

Yes

If not, when did you stop taking or using our product?

date stopped(Required)

DD slash MM slash YYYY

Note: If you do not know the precise date, please provide an accurate guess.

What side effects are you experiencing?(Required)

When did these side effects start?(Required)

DD slash MM slash YYYY

Note: If you do not know the precise date, please provide an accurate guess.

Are you still experiencing these side effects?

Yes

Other (please specify)

Note: If you do not know the precise date, please provide an accurate guess.

Other

For which medical condition are you taking or using our product?

Were you taking or using any other medicines at the time you noticed the side effects?

Is there any other relevant information you wish to share? This could be because you had a cold at the time, have or had other medical conditions, or are allergic to certain medicines.

If applicable: has there recently been a change to the dosage of our product?

If so, when did this change take effect?

As of when?

DD slash MM slash YYYY

Has your report been submitted to the Netherlands pharmacovigilance centre Lareb?(Required)

No. If you have not submitted a report, we will do this on your behalf.

Yes. If you have submitted a report, please mention the report number given by Lareb.

Enter the report number here:(Required)

With your consent, we would like to receive the following patient data:(Required)

Yes

No, I do not wish to share this data.

The following patient data: Your initials, date of birth, age, sex

Your initials(Required)

Date of birth(Required)

DD slash MM slash YYYY

Age(Required)

Sex(Required)

contact details of the reporter

Name(Required)

Telephone number

E-mail address(Required)

Person filing report(Required)

Patient

Pharmacist

Clinician

Other (please specify)

Other

May we contact you to follow up on your report?(Required)

Yes

Privacy(Required)

Yes, I agree with the privacy policy

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How can I submit a complaint about a Focus Care medicine?

Name(Required)

Telephone number

E-mail address(Required)

Person filing report

Melder

Product to which your complaint relates(Required)

RVG (national marketing authorisation) number

The number of product batches to which the complaint relates

LOT- or Batch- number(s)

Details of complaint. Please provide a clear description of your complaint.(Required)

You may upload a document or image in support of your complaint below. This may be a photo of the product, the packaging, a prescription, etc.

Drop files here or

Max. file size: 128 MB.

May we contact you to follow up on your complaint?(Required)

Yes

Yes, I agree with the privacy policy

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